Randomized Clinical Trial of Multicomponent and Functional Exercise Protocols on Functional Capacity, Muscle Strength, Balance and Mental Health in Community-Dwelling Older Adults in Angola
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Aveiro University
- Enrollment
- 350
- Primary Endpoint
- Dynamic Balance - Four Square Step Test (FSST)
Overview
Brief Summary
This study will investigate whether two different physiotherapy exercise programs can improve physical function, balance and mental well-being in older adults living in the community in Angola.
A total of 350 people aged 60 years or older will take part in the study. Participants will be randomly assigned to one of two supervised exercise programs. One group will participate in a multicomponent exercise program that includes strength, balance, walking and coordination exercises. The second group will participate in a reduced functional exercise program focused on basic strengthening, walking and simple daily activities. Both programs will be performed three times per week, with each session lasting 60 minutes, over a period of 12 weeks.
Participants will be assessed before and after the exercise program. The assessments will include tests of balance, muscle strength, walking ability and questionnaires about daily activities and mental health. Information about falls, blood pressure and general health will also be collected.
The goal of this study is to identify effective and safe physiotherapy strategies to help older adults maintain independence, reduce the risk of falls and support healthy ageing, especially in settings with limited health resources.
Detailed Description
This randomized, controlled, parallel-group clinical trial is designed to compare the effects of two supervised physiotherapy exercise programs on functional capacity, muscle strength, balance and mental health in community-dwelling older adults in Luanda, Angola.
A total of 350 participants aged 60 years or older will be recruited from the Viana Rehabilitation Center and the surrounding community. After baseline assessment, participants will be randomly allocated in a 1:1 ratio to one of two intervention groups: a multicomponent exercise program or a reduced functional exercise program. Randomization will be generated using a computerized system with block-balanced sequences stratified by sex and age groups (60-69, 70-79, and ≥80 years). Allocation will be managed by an independent researcher not involved in assessments or interventions.
Both intervention programs will be delivered over a 12-week period, with three supervised sessions per week, each lasting 60 minutes. Sessions will be conducted in group settings by trained physiotherapists following standardized protocols. All physiotherapists involved in the study will receive prior training to ensure consistency and fidelity of the interventions.
Assessments will be conducted at baseline (week 0) and immediately after the intervention period (week 12). Outcome assessors and the statistician will be blinded to group allocation. Data collection will include functional performance tests, muscle strength measures, anthropometric indicators, cardiovascular parameters, and validated questionnaires assessing functional independence and mental health. Information on falls, adherence to sessions and adverse events will be recorded throughout the study.
Statistical analysis will follow the intention-to-treat principle. Changes over time and differences between groups will be analyzed using appropriate parametric or non-parametric methods, depending on data distribution, with a predefined level of statistical significance.
The study will be conducted in accordance with the Declaration of Helsinki and has been or will be approved by the National Institute of Health Research (INIS - Angola). Written informed consent will be obtained from all participants prior to any study procedures. The findings of this trial are expected to contribute to evidence-based physiotherapy strategies aimed at preventing functional decline, reducing fall risk and promoting healthy ageing in low- and middle-income settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors are blinded to group allocation. No other parties are blinded in this trial.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥60 years. Community-dwelling older adults recruited from the Viana Rehabilitation Center and surrounding community in Luanda, Angola.
- •Able to ambulate independently (with or without assistive devices). Able to understand and follow simple instructions (adequate hearing and cognitive capacity for participation).
- •Willing and able to attend supervised exercise sessions three times per week for 12 weeks.
- •Provides written informed consent.
Exclusion Criteria
- •Clinically unstable medical conditions (e.g., decompensated heart failure, uncontrolled hypertension, acute infection, or other conditions making exercise unsafe).
- •Recent stroke or other acute neurological event with unstable clinical status. Severe neurodegenerative disease with significant disability (e.g., advanced dementia or severe Parkinson's disease).
- •Any medical contraindication to moderate-intensity exercise as judged by a physician/clinical team.
- •Participation in a structured exercise program in the last 3 months.
Arms & Interventions
Multicomponent Exercise Program
Braço 1 - Multicomponent Exercise Program (≈180 palavras) Participants allocated to Arm 1 will receive a supervised multicomponent physiotherapy exercise program designed to improve functional capacity, muscle strength, balance and mental health in community-dwelling older adults. The intervention will last 12 weeks, with three sessions per week, each session lasting 60 minutes. Sessions will be conducted by trained physiotherapists in a group-based format.
Each session will include an initial warm-up phase with joint mobility exercises and light walking, followed by global strengthening exercises targeting upper limbs, lower limbs and trunk using bodyweight and elastic bands at moderate intensity. Balance training will involve static and dynamic tasks, including dual-task cognitive challenges such as walking while performing simple attention or memory activities. Functional mobility training will include gait exercises with obstacles, changes of direction and functional transitions.
Intervention: Multicomponent Physiotherapy Exercise Program (Behavioral)
Braço 2 - Reduced Functional Exercise Program - Participants allocated to this arm will receive a su
Braço 2 - Reduced Functional Exercise Program (≈105 palavras) Participants allocated to this arm will receive a supervised reduced functional physiotherapy exercise program over a 12-week period, with three sessions per week lasting 60 minutes each. The intervention is designed to target essential functional abilities in community-dwelling older adults. Sessions include a light warm-up with joint mobility and slow walking, followed by strengthening exercises focused on the lower limbs such as adapted squats, sit-to-stand repetitions and heel raises. Linear walking on a flat surface is incorporated to improve gait stability and posture control. Basic functional tasks, including transfers, reaching movements and simple standing balance activities, are practiced to reinforce daily functional performance. Sessions conclude with stretching and relaxation exercises.
Intervention: Reduced Functional Physiotherapy Exercise Program (Other)
Outcomes
Primary Outcomes
Dynamic Balance - Four Square Step Test (FSST)
Time Frame: Baseline (week 0) and post-intervention (week 12)
Dynamic balance assessed using the Four Square Step Test (FSST), which measures the time in seconds required to step forward, sideways and backward through four marked squares in a standardized sequence without touching obstacles. Lower completion times indicate better dynamic balance performance.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rita de Cassia de Santa Barbara
Prof. Mestre Rita De Cassia De Santa Bárbara
Aveiro University