NCT06886867

Brief Summary

The objective of this clinical trial is to compare the effects of exergaming and usual care physical therapy on physical function in older adults residing in nursing homes. This trial seeks to answer the following key questions:

  • Does physical function differ between interventions after treatment?
  • How do these interventions impact enjoyment of therapy?
  • Are there differences in adherence or perceived exertion between the interventions?

Trial Health

75
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Mar 2025

Geographic Reach
1 country

5 active sites

Status
active not recruiting

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 Progress84%
Mar 2025Jul 2026

First Submitted

Initial submission to the registry

March 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

March 3, 2025

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical function

    Physical function will be assessed using the Short Physical Performance Battery (SPPB)

    Baseline, post-intervention (6 weeks) and 3 months follow-up.

Secondary Outcomes (4)

  • Hand grip strength

    Baseline, post-intervention (6 weeks) and 3 months follow-up.

  • Exercise enjoyment

    Post-intervention (6 weeks)

  • Rate of Perceived Exertion

    RPE will be measured inmediatley after the intervention

  • Adherence

    Through study completion (6 weeks), with a final adherence percentage calculated at the end of the intervention.

Study Arms (2)

Exergaming

EXPERIMENTAL

This group will perform approximately 28 minutes of exergaming 3 times a week for 6 weeks

Other: Exergaming

Usual physical therapy care

ACTIVE COMPARATOR

This group will perform their usual care exercises treatments for approximately 28 minutes for 3 times a week for 6 weeks

Other: Usual physical therapy care

Interventions

Exergaming: Participants will perform different exercises through videogames

Exergaming

Usual care: Different exercises will be performed

Usual physical therapy care

Eligibility Criteria

Age60 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects over 60 years of age
  • score equal to or greater than 20 on the Mini Mental cognitive test
  • Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.

You may not qualify if:

  • severe visual impairment
  • medical contraindication for physical activity
  • pathology or problem that could prevent the test from being carried out.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Residencia de Mayores VIVENS

Añover de Tajo, Toledo, 45250, Spain

Location

Nueva Esperanza Nursing Home

Fuensalida, Toledo, 45510, Spain

Location

Residencia Maranatha

Magán, Toledo, 45590, Spain

Location

Residencial Montes de Toledo

Manzaneque, Toledo, 45460, Spain

Location

Universidad de Castilla-La Mancha

Toledo, Toledo, 45071, Spain

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 20, 2025

Study Start

March 5, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations