Multicomponent Exercise Program on Physical Function, Cognition and Falls Risk Among Older Adults Living in Nursing Homes (MOVE4CARE)

NCT07392944 | Recruiting

• 1 other identifier: CEFADE322025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Dementia

Keywords

Exercise; Frailty; Nursing homes; Multicomponent exercise; Falls; Cognitive function; Physical performance

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  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

Study Arms (2)

Multicomponent exercise

EXPERIMENTAL

Supervised multicomponent exercise training.

Other: Multicomponent exercise intervention

stretching and relaxation program

ACTIVE COMPARATOR

Stretches, deep breathing and relaxation exercises

Other: stretching and relaxation program

Interventions

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.

Multicomponent exercise

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.

stretching and relaxation program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Faculty of Sports, University of Porto

Porto, 4000, Portugal

RECRUITING

MeSH Terms

Conditions

Frailty; Dementia; Motor Activity

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Joana Carvalho, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Joana Carvalho, PhD

CONTACT

+351 220425316; Jcarvalho@fade.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: External investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 6, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)