NCT05668442

Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes

Online Physical Exercise and Group Sessions to Increase and Maintain Physical Activity in Individuals With Type 2 Diabetes: A Single-Arm Feasibility Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Mathias Ried-Larsen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The aim of this study is to evaluate the feasibility, fidelity and acceptability of an 8-week high intensity online physical exercise combined with online group meetings and supported with an activity tracker in individuals with type 2 diabetes. The design of the intervention will be developed using a co-creation approach. The intervention consist of eight weeks of 30 minutes online physical exercise followed by 30 minutes of online group meeting in Microsoft Teams once a week. Outcomes includes pre-defined research progression criteria and secondary outcomes of physical and mental health and participant feedback.

Detailed description

The study is designed as a one-armed feasibility for the reason that the progression criteria are linked to the intervention. No blinding will be applied in the study. The study will be carried on the Centre for Physical Activity Research, Rigshospitalet, Denmark. Reporting of the study will be following the CONSORT extension to a randomized pilot and feasibility trials. Participants will be recruited from the Capital Region of Denmark and Region Zealand using different recruitment strategies followed by a telephone screening with the project coordinator.

Conditions

• Type 2 Diabetes
• Type2diabetes
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Online exercise and group meetings	The intervention consists of 8 weeks of 30 minutes of online supervised high intensity physical exercise followed by 30 minutes of online group meeting once a week in Microsoft Teams. The program consist of a short warm-up, followed by interval.-based physical activity including bodyweight aerobic and strength training, followed by stretching. Following the online exercise session, participants will be sent out in smaller break-out rooms in Microsoft Teams. The online group meeting sessions are intended to serve as a platform for group discussion evaluation of weekly physical acitvity. Each online group will be facilitated by a participant. All participants will be encouraged to set physical activity goals to increase habitual physical activity As a part of the intervention, participants will wear a Garmin Vivofit 4 activity watch or a Garmin 245 watch.

Timeline

• Start date: 2020-11-21
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2022-12-29
• Last updated: 2023-01-03

Locations

1 site across 1 country: Denmark