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NCT Number: NCT07392944

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Sports, University of Porto

Porto, 4000, Portugal

Location status: Recruiting

Location contact

Joana Carvalho, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to ambulate (with or without assistance);
  • Ability to perform chair stands (with or without assistance);
  • Ability to understand and properly follow testing procedures.

Exclusion criteria

  • 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.

Treatment and study plan

multicomponent exercise intervention

Other

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 program

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change from Baseline on Timed Up and Go (TUG)

    Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up

    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.

  2. Change from Baseline on Handgrip test

    Time frame: Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up

    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

  3. Falls rate

    Time frame: Weekly tracking over 18-week study period

    The number of self-reported falls during the 12-week intervention period (i.e., rate of falls) and follow-up (without intervention).

  4. 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

    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.

  5. 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

    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

  6. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Joana Carvalho, PhD

CONTACT

[email protected]

+351 220425316

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Registry information

Official study title

Effects of a Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes: MOVE4CARE

Acronym: MOVE4CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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