NCT07686146

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 25, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

multicomponent exercisefrailtyolder adultsnursing homesbalance trainingfunctional performancefall preventionphysical therapyinstitutionalizad elderly

Outcome Measures

Primary Outcomes (1)

  • Frailty assessed by the Short Physical Performance Battery (SPPB)

    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.

    Baseline to 8 weeks

Secondary Outcomes (5)

  • Balance assessed by the Performance-Oriented Mobility Assessment (POMA)

    Baseline, 8 weeks, and 20 weeks

  • Sarcopenia assessed by SARC-F

    Baseline, 8 weeks, and 20 weeks

  • Functional independence assessed by the Barthel Index

    Baseline, 8 weeks, and 20 weeks

  • Fear of falling assessed by Short FES-I

    Baseline, 8 weeks, and 20 weeks

  • Number of falls

    Throughout the 20-week study period

Study Arms (2)

Multicomponent Exercise Program (BASE)

EXPERIMENTAL

Participants engaged in a supervised multicomponent exercise program including strength and balance training, performed twice weekly for 8 weeks.

Behavioral: Multicomponent Exercise Program (BASE)

Usual Care

OTHER

Participants continued their usual care and routine activities provided by their nursing homes.

Other: Usual Care

Interventions

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.

Multicomponent Exercise Program (BASE)

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

Also known as: Standard care
Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neurodegenerative diseases
  • Advanced dementia
  • Parkinson's disease
  • Hemodynamic instability
  • Lower limb fractures under rehabilitation within the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escoles Universitàries Gimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

MeSH Terms

Conditions

Frailty

Interventions

AlkaliesStandard of Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No blinding was used due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were allocated by residential center to either an intervention group or a control group in a non-randomized parallel design. The intervention group received a multicomponent exercise program, while the control group continued usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 7, 2026

Study Start

November 30, 2021

Primary Completion

January 31, 2022

Study Completion

December 31, 2022

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations