F1000Research F1000Research 2046-1402 F1000 Research Limited London, UK 10.12688/f1000research.139965.1 Study Protocol Articles Effect of aerobic training versus brain gym exercises to improve global cognition and quality of life in elderly - a randomised clinical trial protocol

[version 1; peer review: 1 approved with reservations]

 Budhwani Yukta Conceptualization Methodology Writing – Original Draft Preparation https://orcid.org/0000-0002-4857-4658 a 1 Patil Dr. Shubhangi Supervision Validation Writing – Review & Editing 1 Community Heath Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education & Research., Wardha, Maharashtra, India budhwaniyukta@gmail.com

No competing interests were disclosed.

 15 1 2024 2024 13 66 8 8 2023 Copyright: © 2024 Budhwani Y and Patil DS 2024 This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Literature implies that the length of life spent in good health continues to be fairly stable, indicating that additional years usually deteriorate health The aftermath for older people and society will be more profound if these extra years are primarily marked by declines in physical and mental competence. The cultures and settings individuals live in, paired with their personality traits have a lasting impact on how they age. Health can be shaped by physical and social environments that influence wellness practices. It is therefore essential to consider environmental and personal strategies as well as those that could aid in recovery, adaptation, and psychosocial development while constructing a public health response to aging.

According to research, over the next three decades, there will be a more than doubling of the global elderly population. There will be 1.25 billion more people over the age of 60 in 2050, and 115.4 million of those people are expected to have dementia. 48 million people worldwide are affected by Alzheimer's disease, which accounts for 60–70% of dementia cases and causes serious societal, financial, and clinical issues. This alarms for a solution for the plethora of problems that arise with advancing age. Giving up a sedentary lifestyle and incorporating physical activity into daily activities has shown some amazing results in not only lowering the risk of developing serious illnesses but also 10 improving quality of life. Numerous studies have been conducted in recent years to determine how aerobic exercise and brain gymnastics can each improve health and life expectancy in the elderly, but relatively fewer researches have been done on how these two activities can work together. Consequently, here we intend to probe how aerobic exercise and brain training can enhance general cognition and overall quality of life.

 Geriatric health aerobic training cognition quality of life brain gym exercises older adults physiotherapy. The author(s) declared that no grants were involved in supporting this work. Introduction

With more than 0.26 billion elderly people, Asia is the region with the largest proportion of the world's elderly population. 1 It is anticipated that the aggregate number of people older than 65 years will spike upto1.5 billion in the next three decades, which is almost double. 2 From a physiological perspective, aging is linked to the accumulation of an array of tissue damage over time. As a result, physical and mental abilities gradually deteriorate, disease risk increases, and eventually, death occurs. These changes are neither linear nor consistent, and they only tangentially correspond to an individual's age expressed in years. Aging features the beginning of various complex health disorders like Alzheimer’s disease, dementia, diabetes, hypertension, etc that can further lead to many secondary problems. 3 The implications are more pronounced if these extra years are primarily marked by declines in physical and mental capacity. 4

As we grow older, our physical and mental abilities deteriorate, making us more likely to contract diseases associated with getting older. An aging body's physical degeneration manifests as a reduction in the strength of the muscles resulting in improper balance and gait abnormalities. 5 These impairments raise the risk of falling in combination with their diminished cognitive abilities. A fall occurs on average once a year for more than 30% of people who are 65 or older, which is the traditional age at which someone is considered elderly. It is essential to lower the risk of falling among this population to stop further effects from occurring because of such events. The reduction of bodily functions that has a detrimental effect on balance control is meant to be accelerated by inactivity. Thus, it has been demonstrated that engaging in physical activity can mitigate this occurrence. 6

Exercising has a significant positive impact on cardiovascular health as well as mental and cognitive health, making it the most efficient long-term vaso-protective non-pharmacological treatment. It has been illustrated to foster vascular plasticity. 7 Exercising daily lowers blood pressure and lipid levels, prevents metabolic syndromes, and has favorable effects on inflammatory markers and endothelial functions, all of which have been linked to an elevated probability of Alzheimer's disease. Additionally, studies in recent literature demonstrate that aerobic exercise can increase the volume of the hippocampus, which can stimulate neurological development and raise the complexity of dendritic networks.

This increase in volume results in better memory performance. As a result, physical therapy may be neuroprotective, and beginning an exercise program later in life is not pointless for increasing brain volume or improving cognition. In addition to improving task performance, aerobic exercise increases regional blood flow in several relevant brain structures, particularly in the hippocampus, in response to cognitive tasks. Even in the presence of cognitive impairment, cognitive training, and physical activity have been found to be effective ways to enhance cognitive function in older people.

Yet another advancement to these various physical therapy techniques is the brain gymnasium or brain gym exercises. 8 Brain gym can reawaken the human reticular activating system, which serves as an alertness center. It gives the necessary stimulus to the corpus callosum, which maintains numerous two-way neural connections between the cortical regions of both hemispheres of the brain, including the hippocampus and amygdala. The hippocampus links specific memory components stored in various brain regions and serves as a cross-reference system for consolidation. This affects variations in neuronal memory and boosts nucleic acid. 9 Exercises like brain gymnastics help the body's electromagnetic energy travel throughout the body by reactivating neural pathways that link the brain and body. All mental and physical events undergo electrical and chemical changes, which are supported by this movement. 10

Thus, this study aims to investigate how aerobic exercise and brain gym activities for the elderly affect their overall quality of life by measuring improvements in their cardiovascular health and cognitive function.

Aim of the study

To study the effect of Aerobic training and Brain gym exercises on global cognitive function and improving the Quality of life in the geriatric population.

 Objectives of the study

To find the effect of aerobic training and brain gym exercises in improving global cognition using the Montreal Cognitive Assessment (MoCA) in older adults.

To investigate the effect of aerobic training and brain gym exercises in improving strength and balance and reducing the risk of falls in the elderly by utilizing the Modified Falls Efficacy Scale (MFES).

To determine the impact of aerobic training and brain gym exercises on cardiovascular and mental health and improving the performance of Activities of Daily Living by using The Borg Rating of Perceived Exertion (RPE) scale and the Lawton-Brody Instrumental Activities of Daily Living (IADL).

To evaluate the effects of aerobic exercise and the combination of aerobic exercise and brain-gym exercises to enhance global cognition and quality of life in the elderly by utilizing the Older People’s Quality of Life Questionnaire (OPQOL-35).

Trial Design- Single-centric, open label, two-arm parallel equivalence randomized clinical trial.

 Protocol

All participants will have provided written informed consent prior to the study's execution. The participants will be chosen from the Community Physiotherapy OPD at Acharya Vinobha Bhave Hospital Sawangi (Meghe) at Wardha, Maharashtra, following approval from the institutional ethics committee of Datta Meghe Institute of Higher Education and Research. Participants in the study will be split into two groups. Group-A (Aerobic training group) and Group B (Brain gym exercise group) by randomization for 1:1 allocation with intent to treat purpose. The participants will be screened as per inclusion and exclusion followed by randomization using a computer-generated list. Allocation will be done by sequentially numbered opaque sealed envelopes. Allocation and participant enrolment will be done by the primary investigator. The inclusion and exclusion criteria for selection will be based on the cut-off values at baseline parameters when engaging participants. Throughout the six-month recruitment phase, a second source of recruitment will be used if more study participants are needed. To compare improvements in the Montreal Cognitive Assessment (MoCA), Lawton-Brody Instrumental Activities of Daily Living (IADL), Older People’s Quality of Life Questionnaire (OPQOL-35), Modified Falls Efficacy Scale (MFES) and The Borg Rating of Perceived Exertion (RPE) scale, Group-A will receive aerobic training and Group-B will receive brain gym exercises. Participants will be enrolled and evaluated at several intervals, including the first visit and second visit for subject enrolment and screening respectively, baseline, four weeks, and two weeks after treatment for follow-up, when primary and secondary parameters will be measured ( Figure 1).

Flowchart of the procedure. Inclusion criteria

Both males and females

Age group between 60 to 80 years

Those who can comprehend and follow instructions

Those who intend to partake in the study

Those who do not have any medical contraindications to exercising

Those who can ambulate independently

Exclusion criteria

Those who have moderate/severe cognitive impairments

Those who are diagnosed with any other neurological disorder

Those who have severe ophthalmological/auditory disorders

Those diagnosed with chronic cardiorespiratory conditions

Those diagnosed with any severe orthopedic condition that can limit the participant from exercising

Those who are registered in any other clinical trial

Outcome measures Primary outcome measures

Montreal Cognitive Assessment (MoCA)- MoCA is a screening tool used to assess the cognitive status of individuals. MoCA has a 30-point score. Mild cognitive impairment is indicated by a cutoff score of 26. Numerous types of cognitive impairments can be diagnosed, tracked, and managed with the help of quick, simple, and accurate cognitive assessments. The MoCA helps determine the comprehension and skill level of a patient. The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. According to studies, the specificity of the MoCA is 87% and the reliability is 0.92. 11

Older People’s Quality of Life Questionnaire (OPQOL-35)- The Older People’s Quality of Life questionnaire is a specifically and systematically framed set of simple questions that help us comprehend the quality of life in the geriatric population. 12

Secondary outcome measures

The Borg Rating of Perceived Exertion (RPE) scale- The Borg Rating of Perceived Exertion (RPE) scale, created by Swedish researcher Gunnar Borg, measures a person's effort and exertion, breathlessness, and fatigue during physical work and is therefore extremely pertinent for occupational health and safety practice. 13

Modified Falls Efficacy Scale (MFES)- The MFES is designed to be used in the adult population to gauge how worried an individual is about falling while engaging in social and physical activities inside and outside the home, regardless of whether they participate in them. An updated version of the original 10-item Falls Efficacy Scale, this 14-item activity questionnaire includes additional data. The FES does not cover outdoor activities like transportation, crossing streets, light gardening, or hanging out laundry. It is a widely utilized scale with a reliability of 0.95.

Lawton-Brody Instrumental Activities of Daily Living (IADL)

Lawton's Instrumental Activities of Daily Living Scale was created to evaluate more difficult tasks (also known as “instrumental activities of daily living”) required for interacting with others in a community (e.g., shopping, cooking, managing finances). Prior to the basic "activities of daily living" (ADLs) that are measured by ADL scales, such as eating, bathing, and urinating, the ability to manage these complex functions normally is lost. As a result, evaluating IADLS may help to spot early signs of decline in older adults or other otherwise capable and healthy people. The IADL has been used in over 3000 published studies, and there is a large body of evidence supporting its validity and concurrent reliability. 14

Safety outcomes: To avoid any potential adverse events, required precautions shall be considered, and if any shall be reported appropriately.

Sample size calculation

Formula Using Mean Difference n 1 = n 2 = 2 Z α + Z β 2 σ 2 δ 2 Z α = 1.96 α = TypeIerrorat 5 % at both sides two tailed Z β = 1.64 = Power at 95 %

Primary Variable = Montreal Cognitive Assessment (MoCA)

mean ± sd value over Montreal Cognitive Assessment (MoCA) for Aerobic Training (Control) = (21.4 ± 2.27) (As Per Reference article).

mean ± sd value over Montreal Cognitive Assessment (MoCA) for Brain Gym Exercises (Experimental) = (23.66 ± 1.92) (As Per Reference article)

The mean difference for Montreal Cognitive Assessment (MoCA) (control vs Experimental) = 2.26 (As Per Reference article)

Pooled standard deviation = (2.27 + 1.92) /2 = 2.095. Sample size N = n 1 = n 2 = 2 1.96 + 1.64 2 2.095 2 2.26 2 = 23 per group

Considering 10% dropout = 2

Total sample size required = 23+2 = 25 per group.

Reference Article:- Evidence of effect of aerobic exercise on cognitive intervention in older adults with mild cognitive impairment. 15

Statistical analysis plan

Results over the outcome variables will be tabulated and described using descriptive statistics; data over the outcome variables will be tested for normal distribution for the mean and standard deviation (SD) median statistics will be positioned for finding skewed distributions and interquartile range (IQR). frequency and percentages for binary and categorical variables will be tabulated for descriptive statistics. R-software free version will be used for all statistical analysis. The inferential statistics will be analyzed as per the description given below.

Inferential statistics will be used for comparing the two groups for measurement scores resulting in their mean change in primary variables (Montreal Cognitive Assessment (MoCA) and Older People’s Quality of Life Questionnaire (OPQOL-35) as well as in the secondary variables that will include: The Borg Rating of Perceived Exertion (RPE) scale, Modified Falls Efficacy Scale (MFES) and the Lawton-Brody Instrumental Activities of Daily Living (IADL) at baseline, four weeks and two weeks after the intervention. Baseline variables will be tested for finding significance in the mean using Anova or Kruskal Wallis test for more than two assessment periods. Post-hoc (Tuckey’s or Dunccan) test will be used to find the significance difference between the two groups for pair-wise comparison. Outcome variables will be tested for intra difference in measurement at pre & post-visits using paired t-test for finding the significance in the mean. While for inter-group differences unpaired t-test for the comparison of two groups & Anova for the comparison of three groups will be used. Generalized models for repeated measures will be tested for different visit periods (within the group) & for comparison of three groups (between the group) to find fixed & random effects. For non-normal distribution Mathematical algorithms will be used for conversion of the data to normal distribution. If Data over the primary variable still follows the non-normal distribution, then we will use alternate non-parametric tests (Chi-square, Mann Whitney, Wilcoxon test, Kruskal Wallis, Friedmann test). Following Categorial distribution will be graded for scoring system Chi-square analysis will be performed for categorial evaluation between the control and experimental groups for statistical evidence of finding significance at 5% l.o.s. (P = < 0.05).

t-test unpaired or alternative non-parametric test will be used for finding significance at 5% l.o.s. (P = < 0.05) between both groups. Effect size over mean change difference on the primary variable will be measured with a corresponding 95 % confidence interval (CI) & will be presented for finding the significance at a 5% level.

 Dissemination

We plan to present the study protocol in the preceding conference.

 Study status

Yet to begin

 Discussion

One of the major demographic shifts brought on by higher living standards is the aging of the population. Age-related health and social issues have been highlighted by some contemporary research conducted in India, that revealed a significant portion of elderly people were out of work, were either completely or partially dependent on others, and exhibited a variety of health-related issues that can be shaped by alteration in the lifestyle. 16 The World Health Organisation, in conjunction with the Indian Government, conducted a cross-sectional, community-based study of the elderly population 60 years and older at 10 different sites in various states and union territories of India in light of the growing burden of geriatric health in the country. 17

Enumeration from the Government of India shows that cardiovascular diseases are responsible for one-third of deaths among the elderly. Mortality due to respiratory disorders makes up 10% of the total, while infections like tuberculosis make up the remaining 10%. Neoplasm makes up 6% of elderly mortality, while assault, intoxication, and accidents account for less than 4% of cases. Rates of nutritional, metabolic, gastrointestinal, and genito-urinary infections are more or less comparable. Other psychological issues, such as dementia, mood disorders, depression, etc., are also quite widespread in elderly people. 18 With an in-depth examination of the socioeconomic and health issues that India's elderly population is dealing with, this particular study intends to improve global cognition, increase exercise tolerance, reduce the risk of falls, and enhance the quality of life in older adults. To explore the effect of aerobic training and brain gym exercises on the Montreal Cognitive Assessment (MoCA), Rating of Perceived Exertion (RPE) scale, Modified Falls Efficacy Scale (MFES), Lawton-Brody Instrumental Activities of Daily Living (IADL) and Older People’s Quality of Life Questionnaire (OPQOL-35), participants between the age group of 60-80 years will be part of the study. The data analysis shall be recorded at baseline and after the session and contamination of groups shall be prevented to ensure accurate results.

Ethical considerations

IEC no.- DMIHER (DU)IEC/2023/808

IEC approval date- 21/03/2023

CTRI no.- CTRI/2023/06/053656

CTRI registration date- 08/06/2023

 Data availability

No data is associated with this article.

Reporting guidelines

Zenodo- This is the SPIRIT Guideline for, Effect of Aerobic Training versus Brain Gym Exercises to improve Global Cognition and Quality of life in Elderly- a Randomised Clinical Trial.

DOI- 10.5281/zenodo.8162482

Acknowledgements

The authors would like to acknowledge Mr. Laxmikant Umate and Mr. Manoj Patil for their valuable contribution to the sample size calculation and planning of the data analysis for this study .

References Pazan F Wehling M : Polypharmacy in older adults: a narrative review of definitions, epidemiology and consequences. Eur. Geriatr. Med. 2021 Jun;12(3):443–452. 33694123 10.1007/s41999-021-00479-3 PMC8149355 The aging population: demographics and the biology of aging - PubMed. [cited 2023 Jan 31]. Reference Source Nuzum H Stickel A Corona M : Potential Benefits of Physical Activity in MCI and Dementia. Behav. Neurol. 2020 Feb 12 [cited 2023 Jan 29];2020:1–10. 10.1155/2020/7807856 Reference Source Gomez-Pinilla F Hillman C : The influence of exercise on cognitive abilities. Compr. Physiol. 2013 Jan;3(1):403–428. 23720292 10.1002/cphy.c110063 Thomas E Battaglia G Patti A : Physical activity programs for balance and fall prevention in elderly: A systematic review. Medicine (Baltimore). 2019 Jul;98(27):e16218. 31277132 10.1097/MD.0000000000016218 PMC6635278 McPhee JS French DP Jackson D : Physical activity in older age: perspectives for healthy ageing and frailty. Biogerontology. 2016 Jun 1 [cited 2023 Jan 29];17(3):567–580. 26936444 10.1007/s10522-016-9641-0 PMC4889622 Fleg JL : Aerobic Exercise in the Elderly: A Key to Successful Aging. Discov. Med. 2012 Mar 26 [cited 2023 Jan 29];13(70):223–228. Reference Source Mendrofa F Iswanti D Hani U : Efficacy of Brain Gym on the Cognitive Function Improvement of People with Dementia. J. Keperawatan Jiwa. 2020 Nov 26;8:557. 10.26714/jkj.8.4.2020.557-564 Ball K Berch DB Helmers KF : Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271–2281. 12425704 10.1001/jama.288.18.2271 PMC2916176 Ardian I Nuraini N : The Effectiveness of Brain Gym and Brain Vitalization Gym in Increasing Cognitive Function of The Elderly in Pucang Gading Social Rehabilitation Unit of Semarang. NurseLine J. 2018 Jul 11 [cited 2023 Jan 31];3(1):38–45. 10.19184/nlj.v3i1.7001 Reference Source Montreal Cognitive Assessment (MoCA):[cited 2023 Jan 31]. Reference Source Mgbeojedo UG Ekigbo CC Okoye EC : IGBO Version of the Older People’s Quality Of Life Questionnaire (OPQOL-35) Is Valid and Reliable: Cross-Cultural Adaptation and Validation. Inq. J. Med. Care Organ Provis Financ. 2022;59:004695802211262. 10.1177/00469580221126290 Borg Rating of Perceived Exertion (RPE) scale|Occupational Medicine|Oxford Academic. [cited 2023 Jan 31]. Reference Source McMahon E : Lawton –Brody Instrumental Activities of Daily Living Scale (IADL). Yong L Liu L Ding T : Evidence of Effect of Aerobic Exercise on Cognitive Intervention in Older Adults With Mild Cognitive Impairment. Front. Psych. 2021;12:713671. 34354619 10.3389/fpsyt.2021.713671 PMC8329556 Ingle GK Nath A : Geriatric Health in India: Concerns and Solutions. Indian J. Community Med. Off. Publ. Indian Assoc. Prev. Soc. Med. 2008 Oct [cited 2023 Jun 27];33(4):214–218. 10.4103/0970-0218.43225 Reference Source Thakur R Banerjee A Nikumb V : Health Problems Among the Elderly: A Cross-Sectional Study. Ann. Med. Health Sci. Res. 2013 [cited 2023 Jun 27];3(1):19–25. 23634324 10.4103/2141-9248.109466 Reference Source Yadava KN Yadava SS Vajpeyi DK : A study of aged population and associated health risks in rural India. Int. J. Aging Hum. Dev. 1997;44(4):293–315. 10.2190/KWMQ-EV5T-E5VF-ABUY 10.5256/f1000research.153289.r382439 Reviewer response for version 1 Quan Yixue 1 Referee https://orcid.org/0000-0003-0082-1100 Macquarie University, Sydney, Australia

Competing interests: No competing interests were disclosed.

 24 5 2025 Copyright: © 2025 Quan Y 2025 This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. recommendation approve-with-reservations

This is a protocol of a two-month randomised clinical trial that investigates the effects of aerobic training and brain gym exercise on global cognition and quality of life. More details should be provided to ensure replicability and clarity. Please see my specific comments below.

Some key references appear to be missing in the third and fourth paragraphs of the Introduction (e.g., exercise increases the volume of the hippocampus).

It lacks a clear description of the brain gymnasium or brain gym exercises in both the Introduction and Methods sections. Given that this is the primary intervention of the study, it is essential to define and explain this technique for readers who may be unfamiliar with it.

It does not sufficiently explain the rationale for comparing aerobic exercise with brain gym exercises. Why is it important to compare the effects of these two specific interventions? Clarifying the theoretical or empirical basis for this comparison would strengthen the justification for the study and help readers understand its significance.

The final sentence of the Introduction, which introduces the study aim, is unclear: “how … affects overall quality of life by measuring improvements in cardiovascular health and cognitive function”. Cardiovascular health and cognitive function are not direct measures of quality of life. Please rephrase to more accurately reflect the primary outcomes.

The second objective: The Modified Falls Efficacy Scale does not directly measure strength and balance. The authors can consider incorporating more appropriate tools (e.g., Berg Balance Scale) to assess these outcomes.

The fourth objective: it refers to evaluating the combined effects of aerobic exercise and brain-gym exercises. However, the study design only includes two separate groups (Group A – aerobic training; Group B – brain gym exercise), but there is no combined group. Please clarify this objective. Also, the OPQOL-35 only assesses quality of life, but not global cognition. Please ensure the measures align with the corresponding objective.

Protocol section: the timing of assessments is stated as “baseline, four weeks, and two weeks after treatment”. It would be helpful to clarify that the four-week assessment occurs after the baseline.

Sample size calculation: it would be preferable to cite the reference directly rather than referring vaguely to “as per reference article”. Additionally, the method for calculating pooled standard deviation is incorrect - it’s not correct to simply average the two SDs. Please use the correct formula for the pooled SD that combines two groups.  

Both interventions need to be described in greater detail in the protocol to ensure clarity.

Abstract: it devotes considerable space to discussing general risks associated with aging, which detracts from the main focus. Please consider highlighting the study’s purpose and methodology.

Is the study design appropriate for the research question?

Partly

Is the rationale for, and objectives of, the study clearly described?

Partly

Are sufficient details of the methods provided to allow replication by others?

No

Are the datasets clearly presented in a useable and accessible format?

Not applicable

Reviewer Expertise:

physical exercise, cognitive function, meta-analysis

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.