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Completed

NCT Number: NCT07686146

Multicomponent Exercise and Frailty in Nursing Home Residents

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.

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Key information

Conditions

Balance Impairment Fall Risk Frailty Frailty At Older Adults Functional Decline Pathologic Processes Pathological Conditions, Signs and Symptoms Sarcopenia in Elderly

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escoles Universitàries Gimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Multicomponent Exercise Program (BASE)

Behavioral

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.

Usual Care

Other

Participants continued their usual care and routine physical activities provided by the nursing homes without additional structured intervention.

Other names: Standard care

Primary outcomes

  1. Frailty assessed by the Short Physical Performance Battery (SPPB)

    Time frame: Baseline to 8 weeks

    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.

Secondary outcomes

  1. 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.

  2. Sarcopenia assessed by SARC-F

    Time frame: Baseline, 8 weeks, and 20 weeks

    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.

  3. 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.

  4. Fear of falling assessed by Short FES-I

    Time frame: Baseline, 8 weeks, and 20 weeks

    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.

  5. Number of falls

    Time frame: Throughout the 20-week study period

    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.

Sponsors and collaborators

Lead sponsor

Escoles Universitaries Gimbernat

Other

Registry information

Official study title

Effects of a Multicomponent Exercise Program on Frailty in Institutionalized Older Adults: A Multicenter Controlled Study

Acronym: BASE-Frail

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2026
Registry last updated
Jul 7, 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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