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

NCT ID: NCT05668442

Last Updated: 2023-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-21

Study Completion Date

2022-06-06

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mathias Ried-Larsen

OTHER

Sponsor Role lead

Responsible Party

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Mathias Ried-Larsen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mathias R Larsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Physical Activity Research, Copenhagen University Hospita

Locations

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Center for Physical Activity Research

Copenhagen, København N, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36833589 (View on PubMed)

Other Identifiers

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H-21062951

Identifier Type: -

Identifier Source: org_study_id

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