Clinical trial NCT05668442: Feasibility of an Online Exercise Community Among Individuals With Type 2 Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Type2diabetes
Diabetes Mellitus, Type 2
Type2 Diabetes Mellitus
Keywords: Obesity
Feasibility
Physical activity
Type 2 diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Research Progression Criteria
timeFrame: 8 weeks
measure: Participant Recruitment
timeFrame: 3 months
measure: Completion of intervention
timeFrame: 10 weeks
measure: Adherence to online physical exercise
timeFrame: 8 weeks
measure: Adherence to online meeting
timeFrame: 8 weeks
measure: Adherence to goal setting
timeFrame: 8 weeks
measure: Difficulty in participating in the objectively measured physical activity
timeFrame: 8 weeks
measure: Improvement of physical activity
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Questionnaires
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Physical Activity Research
state: København N
Study officials:
affiliation: Center for Physical Activity Research, Copenhagen University Hospita
name: Mathias R Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: