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Clinical Trials/NCT07392944
NCT07392944
Recruiting
Not Applicable

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

Universidade do Porto1 site in 1 country60 target enrollmentStarted: February 18, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Change from Baseline on Short Physical Performance Battery (SPBB)

Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

External investigator

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Multicomponent exercise

Experimental

Supervised multicomponent exercise training.

Intervention: Multicomponent exercise intervention (Other)

stretching and relaxation program

Active Comparator

Stretches, deep breathing and relaxation exercises

Intervention: stretching and relaxation program (Other)

Outcomes

Primary Outcomes

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

  • Change from Baseline on Timed Up and Go (TUG)(Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up)
  • Change from Baseline on Handgrip test(Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up)
  • Falls rate(Weekly tracking over 18-week study period)
  • Change from baseline in global cognitive function as measured by the Montreal Cognitive Assessment (MoCA)(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(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(Baseline, immediately after 12 weeks of intervention and after 18 weeks follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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