FrailtyMOVE4CARENCT07392944
Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes (MOVE4CARE)
A study testing Multicomponent exercise intervention and stretching and relaxation program in people with Frailty and Dementia, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Multicomponent exercise intervention and stretching and relaxation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 18 Feb 2026to 31 Jul 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ability to ambulate (with or without assistance);
- Ability to perform chair stands (with or without assistance);
- Ability to understand and properly follow testing procedures.
Who cannot join
- Any contraindication that precludes exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical conditions;
- Short Physical Performance Battery (SPPB) score < 3 points;
- Participation in any exercise intervention within the past 3 months;
- Simultaneous participation in another clinical trial during the study;
- Planned transfer to another nursing home facility, to home, or to hospitalization during the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Sports, University of Porto
Porto, 4000
Joana Carvalho, PhD, Jcarvalho@fade.up.pt
About this study
Official title: Effects of a Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes: MOVE4CARE
Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home residents.
Read the detailed description
Individuals residing in nursing homes commonly present with physical frailty and/or cognitive impairment. These geriatric syndromes are strongly associated with accelerated functional and cognitive decline, increased dependency, elevated fall risk, higher rates of hospitalization, and increased mortality. Accordingly, long-term care settings require evidence-based interventions capable of preserving functional capacity and cognitive performance while reducing fall incidence. Non-pharmacological approaches, particularly multicomponent exercise training, have demonstrated beneficial effects on physical and cognitive outcomes in institutionalized older adults. Nevertheless, existing evidence remains limited by methodological heterogeneity, underscoring the need for confirmation through rigorously designed randomized controlled trials. Therefore, this study proposes a 12-week randomized controlled trial in older adults living in nursing homes to evaluate the efficacy of a multicomponent exercise training program incorporating resistance and power, balance, and aerobic components on physical function, cognitive performance, and fall prevention.
The primary objective is to determine whether a multicomponent exercise program produces greater improvements in physical and cognitive function and larger reductions in fall rates compared with a stretching and relaxation program used as an active control. Secondary objectives are to assess whether intervention effects are sustained six weeks following program cessation and to examine the moderating influence of specific subgroups, including frail older adults and individuals with dementia, on intervention-related outcomes.
This study will be conducted as a 12-week assessor-blinded randomized controlled trial with a six-week post-intervention follow-up in nursing homes located in Vila Nova de Gaia, Porto District, Portugal. Participants will be randomly allocated to either a multicomponent exercise training group or an active control group. The intervention group will engage in supervised multicomponent exercise training twice weekly on nonconsecutive days to mitigate fatigue and overtraining. Each session will last 50 to 60 minutes and will comprise a standardized warm-up, progressive resistance and power exercises integrated with aerobic and balance training, followed by a cool-down period consisting of stretching and flexibility exercises. The exercise protocol will be aligned with the Global Consensus on Optimal Exercise recommendations for promoting healthy longevity in older adults. The active control group will participate in stretching, relaxation, and deep-breathing exercises, as well as low-intensity seated physical activities. Outcome assessments will be conducted at baseline, post-intervention at 12 weeks, and at follow-up at 18 weeks, with fall events prospectively monitored on a weekly basis throughout the study period.
- Being tested
- Multicomponent exercise intervention, stretching and relaxation program
- Keywords
- Exercise, Frailty, Nursing homes, Multicomponent exercise, Falls, Cognitive function, Physical performance
- Medical subject headings
- Frailty, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent exercise interventionOther
Twice-weekly for the 12-week duration. The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised multicomponent exercise training, performed twice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, progressive resistance and power exercises combined with aerobic and balance activities, and a 5-min cool-down period (stretching and flexibility movements). The exercise protocol will follow the Global Consensus on Optimal Exercise recommendations for enhancing healthy longevity in older adults.
stretching and relaxation programOther
Twice-weekly for the 12-week duration. The active control Program consist of stretches, deep breathing and relaxation techniques, general (light intensity) physical activity in the sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent exercise | Experimental | Supervised multicomponent exercise training. Receives: Other: Multicomponent exercise intervention |
| stretching and relaxation program | Active comparator | Stretches, deep breathing and relaxation exercises Receives: Other: stretching and relaxation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on Short Physical Performance Battery (SPBB)
The Short Physical Performance Battery (SPPB) is a standardized assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Secondary outcomes (6)
Change from Baseline on Timed Up and Go (TUG)
The Timed Up and Go (TUG) is a standardized assessment of functional mobility. Briefly, the participants will be instructed to rise from a chair, walk 3 meters at their usual pace, turn around, walk back to the chair, and sit down. The time taken to complete the task will be recorded and used as outcome, with longer durations representing poorer functional mobility.
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from Baseline on Handgrip test
Handgrip strength will be obtained with a Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 15s between trials
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Falls rate
The number of self-reported falls during the 12-week intervention period (i.e., rate of falls) and follow-up (without intervention).
Measured: Weekly tracking over 18-week study period
Change from baseline in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a brief, standardized cognitive screening tool, that assesses multiple cognitive domains (global cognitive function), including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The test consists of a 30-point scale and typically requires approximately 10 minutes to administer. Higher scores indicate better cognitive performance.
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from baseline in executive functions as measured by the Trail Making Test (Part A) and Digit Substitution Symbol Test
The Trail Making Test Part A (TMT-A) is a widely used neuropsychological measure of visual attention, processing speed, and psychomotor function. Participants are required to connect numbered circles in sequential order as quickly and accurately as possible. Performance is typically scored by completion time in seconds, with longer times indicating poorer performance. The Digit Symbol Substitution Test (DSST) is a standardized measure of processing speed, attention, working memory, and visuomotor coordination. Participants are asked to match symbols to corresponding numbers according to a reference key within a fixed time (90 seconds). The total number of correct substitutions constitutes the outcome measure, with higher scores reflecting better cognitive performance
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from baseline in mood as measured by the Geriatric Depression Scale
The short-version of the Geriatric Depression Scale (GDS-15) is a brief, screening instrument designed to identify depressive symptoms. The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity.
Measured: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start18 Feb 2026 (estimated)
- Primary completion29 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a parallel-group randomized clinical trial design, consisting of a 12-week intervention period followed by an 18-week observation period without intervention. Data will be collected at three time points: baseline, at 12 weeks (end of the intervention), and at 18 weeks during the post-intervention follow-up phase.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Joana Carvalho, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392944
- Sponsor's protocol ID
- CEFADE322025
- Acronym
- MOVE4CARE
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes: MOVE4CARE
- ClinicalTrials.gov ID
- NCT07392944
- Acronym / sponsor ID
- MOVE4CARE / CEFADE322025
- Keywords
- Exercise, Frailty, Nursing homes, Multicomponent exercise, Falls, Cognitive function, Physical performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 18 Feb 2026 (estimated)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 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.
Can a multicomponent exercise program significantly improve physical and cognitive function and reduce fall rates among nursing home residents? To address this question, the present study aims to compare the effectiveness of a multicomponent exercise program with a stretching and relaxation program in nursing home residents.
Detailed description
Individuals residing in nursing homes commonly present with physical frailty and/or cognitive impairment. These geriatric syndromes are strongly associated with accelerated functional and cognitive decline, increased dependency, elevated fall risk, higher rates of hospitalization, and increased mortality. Accordingly, long-term care settings require evidence-based interventions capable of preserving functional capacity and cognitive performance while reducing fall incidence. Non-pharmacological approaches, particularly multicomponent exercise training, have demonstrated beneficial effects on physical and cognitive outcomes in institutionalized older adults. Nevertheless, existing evidence remains limited by methodological heterogeneity, underscoring the need for confirmation through rigorously designed randomized controlled trials. Therefore, this study proposes a 12-week randomized controlled trial in older adults living in nursing homes to evaluate the efficacy of a multicomponent exercise training program incorporating resistance and power, balance, and aerobic components on physical function, cognitive performance, and fall prevention.
The primary objective is to determine whether a multicomponent exercise program produces greater improvements in physical and cognitive function and larger reductions in fall rates compared with a stretching and relaxation program used as an active control. Secondary objectives are to assess whether intervention effects are sustained six weeks following program cessation and to examine the moderating influence of specific subgroups, including frail older adults and individuals with dementia, on intervention-related outcomes.
This study will be conducted as a 12-week assessor-blinded randomized controlled trial with a six-week post-intervention follow-up in nursing homes located in Vila Nova de Gaia, Porto District, Portugal. Participants will be randomly allocated to either a multicomponent exercise training group or an active control group. The intervention group will engage in supervised multicomponent exercise training twice weekly on nonconsecutive days to mitigate fatigue and overtraining. Each session will last 50 to 60 minutes and will comprise a standardized warm-up, progressive resistance and power exercises integrated with aerobic and balance training, followed by a cool-down period consisting of stretching and flexibility exercises. The exercise protocol will be aligned with the Global Consensus on Optimal Exercise recommendations for promoting healthy longevity in older adults. The active control group will participate in stretching, relaxation, and deep-breathing exercises, as well as low-intensity seated physical activities. Outcome assessments will be conducted at baseline, post-intervention at 12 weeks, and at follow-up at 18 weeks, with fall events prospectively monitored on a weekly basis throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study will employ a parallel-group randomized clinical trial design, consisting of a 12-week intervention period followed by an 18-week observation period without intervention. Data will be collected at three time points: baseline, at 12 weeks (end of the intervention), and at 18 weeks during the post-intervention follow-up phase.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent exercise | Experimental | Other: Multicomponent exercise interventionSupervised multicomponent exercise training. |
| stretching and relaxation program | Active comparator | Other: stretching and relaxation programStretches, deep breathing and relaxation exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Ability to ambulate (with or without assistance);
- Ability to perform chair stands (with or without assistance);
- Ability to understand and properly follow testing procedures.
Key exclusion criteria (5 listed)
- Any contraindication that precludes exercise performance or testing procedures, including terminal illness, uncontrolled disease, or other unstable medical conditions;
- Short Physical Performance Battery (SPPB) score < 3 points;
- Participation in any exercise intervention within the past 3 months;
- Simultaneous participation in another clinical trial during the study;
- Planned transfer to another nursing home facility, to home, or to hospitalization during the intervention.
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 exercise interventionTwice-weekly for the 12-week duration. The exercise intervention will take place at the nursing homes and consists of 12 weeks of supervised multicomponent exercise training, performed twice weekly on nonconsecutive days to avoid overtraining and fatigue. Each session will last 50-60 min and consist of a warm-up, progressive resistance and power exercises combined with aerobic and balance activities, and a 5-min cool-down period (stretching and flexibility movements). The exercise protocol will follow the Global Consensus on Optimal Exercise recommendations for enhancing healthy longevity in older adults. | Other | Multicomponent exercise |
| stretching and relaxation programTwice-weekly for the 12-week duration. The active control Program consist of stretches, deep breathing and relaxation techniques, general (light intensity) physical activity in the sitting position. | Other | stretching and relaxation program |
Primary outcome
Change from Baseline on Short Physical Performance Battery (SPBB)
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
The Short Physical Performance Battery (SPPB) is a standardized assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
6 secondary outcomes
Change from Baseline on Timed Up and Go (TUG)
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from Baseline on Handgrip test
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Falls rate
Time frame: Weekly tracking over 18-week study period
Change from baseline in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from baseline in executive functions as measured by the Trail Making Test (Part A) and Digit Substitution Symbol Test
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
Change from baseline in mood as measured by the Geriatric Depression Scale
Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up
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 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Maria Joana Carvalho, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent exercise intervention and stretching and relaxation program in people with Frailty and Dementia, run by Universidade do Porto at 1 site in Portugal.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Maria Joana Carvalho, PhD (+351 220425316, Jcarvalho@fade.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Short Physical Performance Battery (SPBB) (time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up). 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 17 Feb 2026.