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Study Protocol

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]
PUBLISHED 15 Jan 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

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.

Keywords

Geriatric health, aerobic training, cognition, quality of life, brain gym exercises, older adults, physiotherapy.

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

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

  • 2) 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).

  • 3) 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).

  • 4) 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).

099866db-d4d8-471d-b466-dcc1ee110509_figure1.gif

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

  • 1. 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

  • 2. 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

  • 1. 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

  • 2. 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.

  • 3. 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

n1=n2=2Zα+Zβ2σ2δ2
Zα=1.96
α=TypeIerrorat5%atboth sidestwotailed
Zβ=1.64=Power at95%

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 sizeN=n1=n2=21.96+1.6422.09522.262=23pergroup

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

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Budhwani Y and Patil DS. 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]. F1000Research 2024, 13:66 (https://doi.org/10.12688/f1000research.139965.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 15 Jan 2024
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Reviewer Report 24 May 2025
Yixue Quan, Macquarie University, Sydney, Australia 
Approved with Reservations
VIEWS 1
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 ... Continue reading
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Quan Y. Reviewer Report For: 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]. F1000Research 2024, 13:66 (https://doi.org/10.5256/f1000research.153289.r382439)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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VERSION 1 PUBLISHED 15 Jan 2024
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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