NCT06526975

Brief Summary

The objective of this clinical trial is to assess the feasibility of applying different gamified exercises doses in older adults. It will also learn from possible adverse effects of the intervention. The main questions this clinical trial aims to answer are:

  • Are there any differences between heart rate, perceived exertion and enjoyment between groups?
  • Are there any adverse effects? What is the magnitude of these adverse effects?
  • Are there any correlations between gamification time and the occurrence of adverse effects?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 12, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

July 15, 2024

Last Update Submit

November 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Heart Rate

    Heart rate will be measured using polar H10

    Heart rate is measured thourought the intervention, once the intervention is finished (10 to 30 minutes) recording of heart rate will stop.

  • Rate of perceived exertion

    Rate of perceived exertion will be measured using Borg (RPE 6-20). Higher values indicate higher levels of perceived exertion

    RPE will be measured at half time and once the intervention is finished for both groups.

  • Exercise satisfaction

    It will be measured using Physical Activity Enjoyment Scale (PACES). Higher values indicate higher percieved satisfaction/ enjoyment

    It will be measured on the same day intervention finishes, up to 5 hours post-intervention.

  • Adverse effects

    It will be measured using Hooper and Mackinnon wellness questionnaire. Higher values indicate worse perceived effects.

    24 and 48 hours post-intervention

Study Arms (2)

Gamification 10-20'

EXPERIMENTAL

This group will perform between 10 and 20 minutes of exercise through different videogames.

Other: Gamification exercise through a videogame

Gamification 20-30'

EXPERIMENTAL

This group will perform between 20 and 30 minutes of exercise through different videogames.

Other: Gamification exercise through a videogame

Interventions

Different exercises will be performed through a videogame.

Gamification 10-20'Gamification 20-30'

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 (2)

Nueva Esperanza Nursing Home

Fuensalida, Toledo, 45510, Spain

Location

Universidad de Castilla La Mancha

Toledo, Toledo, 45071, Spain

Location

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

July 15, 2024

First Posted

July 30, 2024

Study Start

July 15, 2024

Primary Completion

September 30, 2024

Study Completion

October 1, 2024

Last Updated

November 12, 2024

Record last verified: 2024-10

Locations