Jul 07, 2025

Public workspaceExercise Program for Dementia: Protocol for a Randomized Control Trial

  • Al Amin1,
  • Dr Md Zahid Hossain1
  • 1Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
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Protocol CitationAl Amin, Dr Md Zahid Hossain 2025. Exercise Program for Dementia: Protocol for a Randomized Control Trial. protocols.io https://dx.doi.org/10.17504/protocols.io.n2bvjerrxgk5/v1
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License,  which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: July 05, 2025
Last Modified: July 07, 2025
Protocol Integer ID: 221787
Keywords: Structured exercise program, Cognitive function, Physical function, Older adults, Dementia., exercise program for dementia, senior fitness test, older adults with dementia, structured exercise regimen, exercise program, dementia, structured exercise program, led structured exercise program, week physiotherapist, randomized control trial, dwelling older adult, implementing exercise, improvements in cognitive function, balance scale, physical functioning in community, physical functioning, cognitive function, older adult
Funders Acknowledgements:
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
Abstract
This protocol outlines a randomized controlled trial (RCT) designed to evaluate the effects of a 12-week physiotherapist-led structured exercise program on cognitive and physical functioning in community-dwelling older adults with dementia in Bangladesh. Participants will be randomly assigned to either an intervention group receiving a structured exercise regimen or a control group receiving conventional care.
The expected results include improvements in cognitive function (measured by MMSE, GDS) and physical performance (measured by the Senior Fitness Test, Berg Balance Scale, and handgrip test, Timed Up to Go (TUG), Berg Balance Scale (BBS) and Chair-Stand Test (CST) and other tools) at both post-intervention (12 weeks) and follow-up (36 weeks). This is the original version of the protocol and aims to provide evidence for implementing exercise as a non-pharmacological dementia intervention in low-resource settings.
Materials
Primary Outcome Measures Mini-Mental State Examination (MMSE): A widely used 30-point questionnaire that assesses cognitive impairment. It evaluates orientation, registration, attention and calculation, recall, and language abilities. Scores below 24 generally indicate cognitive decline or dementia. Geriatric Depression Scale (GDS): A self-report tool designed to screen for depression in older adults. The short form consists of 15 yes/no questions that assess mood, energy levels, and interest in activities. Higher scores suggest more severe depressive symptoms. Functional Rating Scale for Symptoms of Dementia (FRSSD): A caregiver-rated scale that evaluates functional abilities in people with dementia. It covers daily activities such as eating, dressing, bathing, and managing finances. Higher scores indicate greater functional impairment. SF-36 Short Edition (Short Form Health Survey): A validated questionnaire that measures health-related quality of life across multiple domains, including physical functioning, mental health, social functioning, and general health perception. The short edition offers a concise overview of well-being. Likert Scale for Sociodemographic Questions: A common rating scale (e.g., 1 to 5 or 1 to 7) used to capture subjective responses about sociodemographic factors such as education, income, satisfaction, and lifestyle. Respondents indicate the degree of agreement or frequency.


Secondary Outcome Measures

  1. Handgrip Strength Test: A simple and reliable test to assess upper body muscle strength using a dynamometer. It reflects overall muscle function and is associated with mobility and frailty.
  2. Timed Up and Go (TUG) Test: Measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back, and sit down. It assesses mobility, balance, and fall risk.
  3. Berg Balance Scale (BBS): A 14-item scale used to evaluate balance and risk of falling in older adults. Tasks include standing on one foot, reaching forward, and turning 360 degrees. Scores below 45 suggest a higher fall risk.
  4. Chair-Stand Test (CST): Assesses lower body strength and endurance by counting how many times a person can rise from a seated position to standing in 30 seconds. It's a key indicator of functional leg strength.
Troubleshooting
Protocol references
Baek, M. J., Kim, K., Park, Y. H., & Kim, S. (2016). The validity and reliability of the Mini-Mental State Examination-2 for detecting mild cognitive impairment and Alzheimer’s disease in a Korean population. PLoS ONE, 11(9), e0163792. https://doi.org/10.1371/journal.pone.0163792

Fitriana, L. A., Adnyana, I. K., Anggadiredja, K., Setiawan, I., Theresa, R. M., & Luu, P. T. (2024). The effectiveness of Centella asiatica extract and aerobic exercise on plasma levels of amyloid beta-42 and phosphorylated tau in older women with dementia. International Journal of Disabilities Sports & Health Sciences, 7(5), 1156–1162. https://doi.org/10.33438/ijdshs.1505669

Lamb, S. E., Sheehan, B., Atherton, N., et al. (2018). Dementia and physical activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: Randomised controlled trial. BMJ, 361, k1675. https://doi.org/10.1136/bmj.k1675

Naheed, A., Hakim, M., Islam, M. S., et al. (2023). Prevalence of dementia among older age people and variation across different sociodemographic characteristics: A cross-sectional study in Bangladesh. The Lancet Regional Health – Southeast Asia, 17, 100257. https://doi.org/10.1016/j.lansea.2023.100257

Papatsimpas, V., Vrouva, S., Papadopoulou, M., Papathanasiou, G., & Bakalidou, D. (2023). The effects of aerobic and resistance exercises on the cognitive and physical function of persons with mild dementia: A randomized controlled trial protocol. Healthcare, 11(5), 677. https://doi.org/10.3390/healthcare11050677

Toots, A., Lundin-Olsson, L., Nordström, P., Gustafson, Y., & Rosendahl, E. (2021). Exercise effects on backward walking speed in people with dementia: A randomized controlled trial. Gait & Posture, 85, 65–70. https://doi.org/10.1016/j.gaitpost.2020.12.028




Acknowledgements
We would like to express our sincere gratitude to the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology (JUST) for partially funding this study. We also thank the faculty members, clinical staff, and all participants whose support and cooperation were essential to the successful execution of this research.