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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668442
• Other study ID #: H-21062951
• Status: Completed
• Start date: November 21, 2020
• Est. completion date: June 6, 2022

Study information

• Verified date: December 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Denmark	Center for Physical Activity Research	Copenhagen	København N

Sponsors (1)

Lead Sponsor	Collaborator
Mathias Ried-Larsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Research Progression Criteria	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	8 weeks
Primary	Participant Recruitment	Evaluation of participant recruitment was made by calculating number of participants recruited within three months.	3 months
Primary	Completion of intervention	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	10 weeks
Primary	Adherence to online physical exercise	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.	8 weeks
Primary	Adherence to online meeting	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.	8 weeks
Primary	Adherence to goal setting	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.	8 weeks
Primary	Difficulty in participating in the objectively measured physical activity	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	8 weeks
Primary	Improvement of physical activity	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	8 weeks
Primary	Adverse events	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	8 weeks
Secondary	Questionnaires	Change in behavioral physical activity measured using a weekly questionnaire and compared at baseline and post-intervention; 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; Change in physical activity measured using a weekly questionnaire and compared at baseline and post-intervention	8 weeks