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

NCT07424274 | Not Yet Recruiting

• 1 other identifier: FUNC-ANGOLA-RCT2025
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ageing; Frailty; Sarcopenia; Decline, Cognitive

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (week 0) and post-intervention (week 12)

Study Arms (2)

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.

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.

Other: Reduced Functional Physiotherapy Exercise Program

Interventions

Multicomponent Physiotherapy Exercise Program BEHAVIORAL

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.

Multicomponent Exercise Program

Reduced Functional Physiotherapy Exercise Program OTHER

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.

Braço 2 - Reduced Functional Exercise Program - Participants allocated to this arm will receive a su

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Related Links

• WHO evidence-based guideline supporting physical activity and exercise interventions for functional capacity and healthy ageing in older adults.
• 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 physiother
• 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.

MeSH Terms

Conditions

Frailty; Sarcopenia; Cognitive Dysfunction; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Rita Santa Barbara, Master Degree

  iBiMED - Instituto de Biomedicina, Universidade de Aveiro, Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Cassia Santa Barbara, Master's Degree (MSc)

CONTACT

244 943673835; cass.barbara@ua.pt

Mario Lopes, PhD

CONTACT

mario.lopes@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. No other parties are blinded in this trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mestre Rita De Cassia De Santa Bárbara

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 20, 2026
• Study Start: February 15, 2026
• Primary Completion: March 20, 2026
• Study Completion: May 20, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share