The Effectiveness of an Exergame-based Intervention

Blood Pressure Clinical Trial

Official title:

Evaluation of the Effectiveness of Regular Training in the ExerCube - A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05712317
• Other study ID #: 2021-03-00006
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: University of Bern
• Contact: Sascha Ketelhut, Dr.
• Phone: +41799412752
• Email: sascha.ketelhut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized control trial aims to compare the effects of a regular exergame-based intervention and a regular moderate-intensity endurance exercise in healthy individuals. The main questions it aims to answer are:

• Is regular exergame-based training an effective intervention to improve different health and performance parameters in healthy adults? Can the exergaming intervention improve health and performance parameters similar to a moderate-intensity endurance exercise intervention? Throughout the intervention period (8 weeks), participants will participate in regular training sessions (3x/week) in an exergame called the ExerCube.

Researchers will compare the effects to a control group who participates in regular (3x/week) moderate-intensity endurance exercise to see if the exergaming intervention induces similar effects on health and performance parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy female and male adults

• Aged 18-60 years

• Free from acute and chronic diseases

• Free from movement restrictions or injuries to the musculoskeletal system

• Provided written informed consent

Exclusion Criteria:

• Underlying health condition that could compromise the safety of the physical exercise

• Were taking cardiovascular medications

Related Conditions & MeSH terms

• Blood Pressure
• Physical Inactivity

Intervention

Behavioral:
• Exergame Intervention
8-week exergame-based intervention 3x per week
• Moderate-intensity endurance exercise
8-week moderate-intensity endurance exercise 3x per week

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline in body mass index at week 8	Height will be measured barefoot with a stadiometer to the nearest 0.5 cm. Body mass will be measured using a scale. Body mass index will be calculated as a function of weight in kilogram and height in meters.	Baseline and week 8
Primary	Changes from baseline in maximum oxygen consumption at week 8	Maximum oxygen consumption will be obtained during a cardiopulmonary exercise test on a bicycle ergometer using a validated metabolic cart.	Baseline and week 8
Secondary	Changes from baseline in pulse wave velocity at week 8	Pulse wave velocity will be obtained non-invasively using a clinically validated device for hemodynamic measurements. After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.	Baseline and week 8
Secondary	Changes from baseline in systolic blood pressure at week 8	Systolic blood pressure will be obtained non-invasively using a clinically validated device for hemodynamic measurements. After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.	Baseline and week 8
Secondary	Changes from baseline in diastolic blood pressure at week 8	Diastolic blood pressure will be obtained non-invasively using a clinically validated device for hemodynamic measurements. After a 10 min supine rest, a minimum of two readings will be performed on the right upper arm using customized arm cuffs.	Baseline and week 8