- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07686146
Multicomponent Exercise and Frailty in Nursing Home Residents (BASE-Frail)
Effects of a Multicomponent Exercise Program on Frailty in Institutionalized Older Adults: A Multicenter Controlled Study
Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population.
This study evaluated the effects of a multicomponent exercise program combining strength and balance training in residents aged 65 years and older. Participants were assigned to either an intervention group, which performed supervised exercise sessions twice a week for 8 weeks, or a control group, which continued their usual activities.
The main outcome was frailty, measured using the Short Physical Performance Battery. Other outcomes included balance, functional independence, sarcopenia, fear of falling, and number of falls.
This study was retrospectively registered.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Frailty is a multidimensional clinical condition highly prevalent among older adults living in institutional settings and is associated with increased risk of falls, disability, hospitalization, and mortality. Despite growing evidence supporting physical exercise interventions, there is still a need for structured, feasible, and clinically applicable programs specifically designed for nursing home residents.
This study aimed to evaluate the effects of a multicomponent exercise program on frailty and related outcomes in institutionalized older adults. A multicenter, controlled, non-randomized design was used, including participants recruited from eight nursing homes.
Participants aged 65 years and older were allocated by residential center to either an intervention group or a control group. The intervention group participated in the Balance and Strength Exercises (BASE) program, consisting of supervised sessions performed twice weekly for 8 weeks. Each session included a combination of strength and balance exercises with progressive levels adapted to individual capacity. The control group continued their usual care and routine activities.
The primary outcome was frailty, assessed using the Short Physical Performance Battery (SPPB). Secondary outcomes included balance, measured with the Performance-Oriented Mobility Assessment (POMA); sarcopenia, measured with the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F); functional independence, measured with the Barthel Index; fear of falling, measured with the Short Falls Efficacy Scale-International (Short FES-I); and the number of falls occurring during the study period.
Assessments were conducted at baseline, immediately after the intervention (8 weeks), and at follow-up (20 weeks). The study evaluated both the immediate effects of the intervention and the persistence of outcomes after cessation.
This study was retrospectively registered following completion of data collection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Sant Cugat del Vallès, Barcelona, Spain, 08174
- Escoles Universitàries Gimbernat
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years or older
- Living in a nursing home
- Ability to walk at least 10 meters (with or without assistive devices)
- Mini-Mental State Examination (MMSE) score ≥19
Exclusion Criteria:
- Neurodegenerative diseases
- Advanced dementia
- Parkinson's disease
- Hemodynamic instability
- Lower limb fractures under rehabilitation within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multicomponent Exercise Program (BASE)
Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.
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A supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.
Each session lasted 30-40 minutes and included warm-up, strength exercises, and progressively adapted balance tasks based on individual capacity.
|
|
Other: Usual Care
Participants continued their usual care and routine activities provided by their nursing homes.
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Participants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty assessed by the Short Physical Performance Battery (SPPB)
Time Frame: Baseline to 8 weeks
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Frailty was measured using the Short Physical Performance Battery (SPPB), which includes assessments of balance, gait speed, and chair rise performance.
Total scores range from 0 to 12, with higher scores indicating better physical performance.
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Baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance assessed by the Performance-Oriented Mobility Assessment (POMA)
Time Frame: Baseline, 8 weeks, and 20 weeks
|
Balance was measured using the Performance-Oriented Mobility Assessment (POMA), which evaluates static and dynamic balance as well as gait performance.
Total scores range from 0 to 28, with higher scores indicating better balance and mobility.
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Baseline, 8 weeks, and 20 weeks
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Sarcopenia assessed by SARC-F
Time Frame: Baseline, 8 weeks, and 20 weeks
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Sarcopenia was measured using the Strength, Assistance with Walking, Rise from a Chair, Climb Stairs, and Falls Questionnaire (SARC-F), a self-reported screening tool for sarcopenia risk.
Total scores range from 0 to 10, with higher scores indicating a greater risk of sarcopenia.
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Baseline, 8 weeks, and 20 weeks
|
|
Functional independence assessed by the Barthel Index
Time Frame: Baseline, 8 weeks, and 20 weeks
|
Functional independence was measured using the Barthel Index, which assesses the ability to perform activities of daily living, including feeding, bathing, dressing, toileting, mobility, and stair climbing.
Total scores range from 0 to 100, with higher scores indicating greater functional independence.
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Baseline, 8 weeks, and 20 weeks
|
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Fear of falling assessed by Short FES-I
Time Frame: Baseline, 8 weeks, and 20 weeks
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Fear of falling was measured using the Short Falls Efficacy Scale-International (Short FES-I), which assesses concerns about falling during everyday activities.
Total scores range from 7 to 28, with higher scores indicating greater fear of falling.
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Baseline, 8 weeks, and 20 weeks
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Number of falls
Time Frame: Throughout the 20-week study period
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Falls were measured as the total number of falls recorded during the study period using incident reports from the participating nursing homes.
Higher values indicate a greater frequency of falls.
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Throughout the 20-week study period
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEEAH-UAB-5654
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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