Study of Different Exercise Doses Through Videogames in Older Adults

Study of Different Exercise Doses Through Digital Gamification in Older Adults

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?

Study Overview

• Status: Completed
• Conditions: Older Adult
• Intervention / Treatment: Other: Gamification exercise through a videogame

Detailed Description

A randomised clinical trial will be conducted in which the use of exercise doses between 10 and 30 will be tested. Participants will be recruited from Nueva Esperanza nursing home, Fuensalida, Toledo. The study will be conducted according to the CONSORT statement for clinical, crossover and parallel trials.

The study will have a total of two experimental groups, with different intervention times, between 10 and 30 minutes, respectively, using a mobile application. The intervention will consist of performing exercise in pairs in a single bout during the mentioned times.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • Universidad de Castilla La Mancha
  • Toledo
    • Fuensalida, Toledo, Spain, 45510
      • Nueva Esperanza Nursing Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gamification 10-20'; This group will perform between 10 and 20 minutes of exercise through different videogames.	Other: Gamification exercise through a videogame; Different exercises will be performed through a videogame.
Experimental: Gamification 20-30'; This group will perform between 20 and 30 minutes of exercise through different videogames.	Other: Gamification exercise through a videogame; Different exercises will be performed through a videogame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HBA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be provided to other researchers if asked to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No