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

NCT05668442 | Completed DMC

• 1 other identifier: H-21062951
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Type2diabetes; Diabetes Mellitus, Type 2; Type2 Diabetes Mellitus

Keywords

Obesity; Feasibility; Physical activity; Type 2 diabetes

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Questionnaires

  8 weeks

Interventions

Online exercise and group meetings BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mathias Ried-Larsen: lead

Study Sites (1)

Center for Physical Activity Research

Copenhagen, København N, 2200, Denmark

Location

Related Publications (1)

• Mortensen SR, Pedersen ME, Skou ST, Ried-Larsen M. Online Physical Exercise and Group Sessions to Increase and Maintain Physical Activity in Individuals with Type 2 Diabetes: A Single-Arm Feasibility Study. Int J Environ Res Public Health. 2023 Feb 7;20(4):2893. doi: 10.3390/ijerph20042893.

  PMID: 36833589 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mathias R Larsen, PhD

  Center for Physical Activity Research, Copenhagen University Hospita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 29, 2022
• Study Start: November 21, 2020
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

DK (1)