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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Type 2 Diabetes; Type2 Diabetes Mellitus; Type2diabetes
• Intervention / Treatment: Behavioral: Online exercise and group meetings

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Denmark
  • København N
    • Copenhagen, København N, Denmark, 2200
      • Center for Physical Activity Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants were recruited within the Capital of Region of Denmark and Region of Southern Zealand. Males and females >18 years old and diagnosed with T2D were included. Furthermore, the participants were required to have access to a device such as a computer, tablet, or a smart phone. The exclusion criteria were contraindications to exercise (e.g., unstable cardiovascular disease, complications/injuries in the locomotive apparatus). Furthermore, participants were excluded if they were advised not to exercise by a doctor or already participating in other intervention trials.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Recruitment	Evaluation of participant recruitment was made by calculating number of participants recruited within three months.	3 months
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mathias Ried-Larsen
• Investigators: Principal Investigator: Mathias R Larsen, PhD, Center for Physical Activity Research, Copenhagen University Hospita

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2020
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Feasibility; Type 2 diabetes; Physical activity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H-21062951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If the data can be fully anonymized the data can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No