Physiotherapy Interventions on Functional Capacity, Balance and Mental Domains in Community-Dwelling Older Adults: A Randomized Clinical Trial With Two Parallel Groups

Official title

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

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.

Interventions

• Behavioral Multicomponent Physiotherapy Exercise Program
  Supervised multicomponent physiotherapy exercise program delivered over 12 weeks, with three 60-minute sessions per week. The intervention includes joint mobility and light walking warm-up, global strengthening of upper and lower limbs and trunk using bodyweight and elastic bands, static and dynamic balance training with dual-task cognitive activities, gait training with obstacles and functional mobility tasks, breathing and coordination exercises, and final stretching and relaxation. The progra
• Other Reduced Functional Physiotherapy Exercise Program
  Supervised reduced functional physiotherapy exercise program delivered over 12 weeks, with three 60-minute sessions per week. The intervention focuses on essential functional abilities in community-dwelling older adults, including joint mobility warm-up, lower-limb strengthening exercises such as adapted squats, sit-to-stand repetitions and heel raises, linear walking on a flat surface to improve gait stability, basic functional tasks such as transfers and simple standing balance activities, and

Primary outcome measures

• Dynamic Balance - Four Square Step Test (FSST) [Time frame: Baseline (week 0) and post-intervention (week 12)]

Eligibility criteria

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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07424274 · FUNC-ANGOLA-RCT2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗