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

February 13, 2026 updated by: Rita de Cassia de Santa Barbara, Aveiro University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rita Cassia Santa Barbara, Master's Degree (MSc)
  • Phone Number: 244 943673835
  • Email: cass.barbara@ua.pt

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 program is designed to improve functional capacity, muscle strength, balance and mental health in community-dwelling older adults.
Active Comparator: 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.
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 final stretching and relaxation exercises. This simplified protocol targets core functional improvements with reduced motor and cognitive complexity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0) and post-intervention (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveiro University

Investigators

  • Principal Investigator: Rita Santa Barbara, Master Degree, iBiMED - Instituto de Biomedicina, Universidade de Aveiro, Portugal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2026

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUNC-ANGOLA-RCT2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared. Only aggregated and anonymized results will be reported in scientific publications and presentations. De-identified data may be made available upon reasonable request to the principal investigator, subject to ethical approval and data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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