NCT07027397

Brief Summary

This study is an exercise intervention assessing the efficacy of a velocity-based resistance training (VBRT) in institutionalized older adults. The aim of this study is to assess the effects of one year of velocity-based resistance training on skeletal muscle mass, muscle function, and physical and cognitive function in older adults living in nursing homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

May 27, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in muscle power

    Muscle power assessed in leg press machine and sit to stand test.

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • Changes in neuromuscular performance of lower-body

    Change in the force-velocity relationship in leg press exercise.

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

Secondary Outcomes (6)

  • Change in physical function based on the Short Physical Performance Battery score

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • Change in frailty (score) using Fried's Frailty Criteria and Frailty Trait Scale - Short Form

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • Change in muscle mass using ultrasonography.

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • Change in disability using Barthel and Lawton scales

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • Change in cognitive function using Mini-Mental State Examination

    T0 (baseline); T1 (post 6 weeks); T2 (post 12 weeks); T3 (post 23 weeks) and T4 (post 39 weeks).

  • +1 more secondary outcomes

Study Arms (1)

Exercise Group

EXPERIMENTAL

a 2-day-a-week resistance training (RT) routine using the velocity-based method in the leg press exercise at 60% of the theoretical maximal isometric strength

Other: Exercise

Interventions

All participants will conduct a 2-day-a-week resistance training (RT) routine using the velocity-based method in the leg press exercise for one year. A tailored and constant intensity will be performed at 60% of the theoretical maximal isometric strength (F0) during the training intervention. Participants will conduct 3-4 sets, individualizing the repetitions numbers until they reach a velocity loss of 10-20%. A rest of 2 minutes was imposed between sets. A standardized warm-up will preced all RT session as follows: 4 minutes walking at usual gait speed and 6 minutes performing dynamic balance exercises.

Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Older people living permanently in nursing home.
  • Age ≥ 65 years old.
  • Are able to walk with/without assistance.
  • Have ability to communicate with the research team.

You may not qualify if:

  • Terminal illness.
  • Any illness not controled (cardiac, pulmonary, etc).
  • If there is a risk of bone fracture according to medical staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Castilla-La Mancha

Toledo, Toledo, 45071, Spain

Location

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Julian Alcazar, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 18, 2025

Study Start

September 30, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations