Ageing, Decline, Cognitive, Frailty, Sarcopenia
Conditions
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
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.
Interventions
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.
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.
Sponsors
Aveiro University
Study design
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Balance - Four Square Step Test (FSST) | 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. |
Contacts
CONTACTRita Cassia Santa Barbara, Master's Degree (MSc)
CONTACTMario Lopes, PhD
PRINCIPAL_INVESTIGATORRita Santa Barbara, Master Degree
iBiMED - Instituto de Biomedicina, Universidade de Aveiro, Portugal
Outcome results
None listed