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

Completed

• Conditions: Type 2 Diabetes; Type2diabetes; Type2 Diabetes Mellitus; Diabetes Mellitus, Type 2

• Registration Number: NCT05668442
• Lead Sponsor: Mathias Ried-Larsen

Brief 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.

Study Timeline

• Study Start: 2020-11-21
• Primary Completion: 2022-06-06
• Study Completion: 2022-06-06
• Study First Submitted: 2022-11-18
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-29
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosed with type 2 diabetes
• Access to a device such as a computer, tablet, or a smart phone

Exclusion Criteria

• Contraindications to exercise, for example heart conditions, complications/injuries in the locomotive apparatus
• Advised to not exercise by medical doctor
• Current participation in other intervention trials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant Recruitment	3 months	Evaluation of participant recruitment was made by calculating number of participants recruited within three months.
Adherence to online physical exercise	8 weeks	Evaluation of adherence to online physical exercise, participants received weekly web-based questionnaires instantly after the online physical exercise to respond whether they attended the session.; Adherence to online physical exercise was calculated by counting the number of completed online meetings separately, divided by the eight planned sessions.
Research Progression Criteria	8 weeks	Research Progression Criteria obtained through self-reported data from weekly questionnaires organized into the following categories: Participant recruitment Completion of intervention Adherence to online physical exercise Adherence to the group meeting Adherence to goal setting Difficulty in participating in the objectively measured physical activity Improvement of physical activity Adverse events
Difficulty in participating in the objectively measured physical activity	8 weeks	Difficulty in participating in the objectively measured physical activity was evaluated with a questionnaire at postintervention regarding participants' satisfaction with applying and wearing the accelerometers during the intervention
Adverse events	8 weeks	Evaluation of adverse events involved experienced severity of adverse events in the postintervention questionnaire according to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®).; Minor adverse events covered dizziness, acute and prolonged musculoskeletal pain, and minor falls. Serious adverse events covered life-threatening events, disability, permanent damage, or hospitalization
Completion of intervention	10 weeks	Evaluation of completion of the intervention was made by calculating the percentage of participants who provided baseline and postintervention data out of the total number of participants at baseline
Adherence to online meeting	8 weeks	Evaluation of adherence to online group meetings, participants received weekly web-based questionnaires instantly after the online meeting to respond whether they attended the session.; Adherence to online meeting was calculated by counting the number of completed online meetings separately, divided by the eight planned sessions.
Adherence to goal setting	8 weeks	During the 8-week intervention, participants wrote down a weekly activity goal for the forthcoming week and if they completed the activity goal from the previous week.
Improvement of physical activity	8 weeks	Evaluation of improvement of habitual physical activity, all participants wore axivity (AX3) (Axivity, Newcastle, UK) accelerometers for seven consecutive days before, during and after the intervention. Accelerometer data was considered valid if the participant had minimum 22 hours wear time out of 24 possible. A measurement period was considered valid, if the participant had at least three valid weekdays and one valid weekend day. Any improvement in habitual physical activity (daily counts per minute) from baseline to postintervention was considered as an improvement

Secondary Outcome Measures

Name	Time	Method
Questionnaires	8 weeks	1. Change in behavioral physical activity measured using a weekly questionnaire and compared at baseline and post-intervention; 2. Change in mental well-being measured using a weekly questionnaire and compared at baseline and post-intervention. Self-reported mental well-being were obtained with the World Health Organization( WHO)-5-Well-Being-Index Health-Related Quality of Life ( HRQoL). Questions were scored from 0 (none of the time) to 5 (all time).; According to the recommendations, the raw score is multiplied by 4 to obtain a percentage score ranging from 0-100. The score was interpreted as following: 2.1. A score \<50 was categorized as low HRQoL and described as being at risk for developing stress and depression 2.2. A score ≥50 was categorized as moderate to high HRQoL; 3. Change in physical activity measured using a weekly questionnaire and compared at baseline and post-intervention

Trial Locations

Locations (1)

Center for Physical Activity Research; 🇩🇰 Copenhagen, København N, Denmark