AgeingNCT07424274
Physiotherapy Interventions on Functional Capacity, Balance and Mental Domains in Community-Dwelling Older Adults: A Randomized Clinical Trial With Two Parallel Groups
A study testing Multicomponent Physiotherapy Exercise Program and Reduced Functional Physiotherapy Exercise Program in people with Ageing and Frailty, run by Aveiro University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ageing, Frailty, Sarcopenia
- What is being tested?
- Multicomponent Physiotherapy Exercise Program and Reduced Functional Physiotherapy Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mario Lopes, PhD contact
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Ageing, Frailty, Sarcopenia, Decline, Cognitive
- Being tested
- Multicomponent Physiotherapy Exercise Program, Reduced Functional Physiotherapy Exercise Program
- Keywords
- Older adults, Physiotherapy, aging, Exercise Therapy, Multicomponent exercise, Balance, Muscle strength, handgrif strenght, Calf Circunferemce, mental health, community dwelling older adults, fall prevention, Activities of daily living
- Medical subject headings
- Frailty, Sarcopenia, Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Physiotherapy Exercise ProgramBehavioural
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.
Reduced Functional Physiotherapy Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Exercise Program | Experimental | 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. Receives: Behavioral: Multicomponent Physiotherapy Exercise Program |
| Braço 2 - Reduced Functional Exercise Program - Participants allocated to this arm will receive a su | Active comparator | 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. Receives: Other: Reduced Functional Physiotherapy Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance - Four Square Step Test (FSST)
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.
Measured: Baseline (week 0) and post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion20 Mar 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group interventional study. Participants are allocated in a 1:1 ratio to one of two supervised physiotherapy exercise programs (multicomponent exercise or reduced functional exercise) and remain in the assigned group for the entire 12-week intervention period, with no crossover or sequential assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita de Cassia de Santa Barbara, Aveiro University
- Investigators
- Rita Santa Barbara, Master Degree, Principal investigator, iBiMED - Instituto de Biomedicina, Universidade de Aveiro, Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424274
- Sponsor's protocol ID
- FUNC-ANGOLA-RCT2025
- Status last verified
- Feb 2026
- First submitted
- 12 Dec 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07424274
- Acronym / sponsor ID
- FUNC-ANGOLA-RCT2025
- Conditions
- Ageing, Frailty, Sarcopenia, Decline, Cognitive
- Keywords
- Older adults, Physiotherapy, aging, Exercise Therapy, Multicomponent exercise, Balance, Muscle strength, handgrif strenght
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group interventional study. Participants are allocated in a 1:1 ratio to one of two supervised physiotherapy exercise programs (multicomponent exercise or reduced functional exercise) and remain in the assigned group for the entire 12-week intervention period, with no crossover or sequential assignment.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Exercise Program | Experimental | Behavioral: Multicomponent Physiotherapy Exercise ProgramBraço 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. |
| Braço 2 - Reduced Functional Exercise Program - Participants allocated to this arm will receive a su | Active comparator | Other: Reduced Functional Physiotherapy Exercise ProgramBraço 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Physiotherapy Exercise ProgramSupervised 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. | Behavioural | Multicomponent Exercise Program |
| Reduced Functional Physiotherapy Exercise ProgramSupervised 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. | Other | Braço 2 - Reduced Functional Exercise Program - Participants allocated to this arm will receive a su |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- WHO evidence-based guideline supporting physical activity and exercise interventions for functional capacity and healthy ageing in older adults.Link provided by the sponsor.
- Scientific evidence demonstrating the effects of dual-task exercise interventions on cognitive-motor performance, balance and functional mobility in older adults, supporting the inclusion of combined cognitive and motor tasks in multicomponent physiotherLink provided by the sponsor.
- World Health Organization global initiative (2021-2030) promoting healthy ageing through actions that enhance functional ability, prevent functional decline and support evidence-based interventions for older adults across health and social care systems.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Lopes, PhD contact
Rita Santa Barbara, Master Degree principal investigator
iBiMED - Instituto de Biomedicina, Universidade de Aveiro, Portugal
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Physiotherapy Exercise Program and Reduced Functional Physiotherapy Exercise Program in people with Ageing and Frailty, run by Aveiro University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Cassia Santa Barbara, Master's Degree (MSc) (244 943673835, cass.barbara@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance - Four Square Step Test (FSST) (time frame: Baseline (week 0) and post-intervention (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.