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Type 2 DiabetesNCT05668442

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

An observational study of Type 2 Diabetes and Type2diabetes, run by Mathias Ried-Larsen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Online exercise and group meetings
How many people
24 participants
Where
1 siteDenmark
Study dates
21 Nov 2020to 6 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Physical Activity Research

    Copenhagen, København N, 2200

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Online exercise and group meetings
Keywords
Obesity, Feasibility, Physical activity, Type 2 diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online exercise and group meetingsBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 weeks

  2. Participant Recruitment

    Evaluation of participant recruitment was made by calculating number of participants recruited within three months.

    Measured: 3 months

  3. 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

    Measured: 10 weeks

  4. 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.

    Measured: 8 weeks

  5. 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.

    Measured: 8 weeks

  6. 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.

    Measured: 8 weeks

  7. 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

    Measured: 8 weeks

  8. 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

    Measured: 8 weeks

  9. 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

    Measured: 8 weeks

Secondary outcomes (1)

  1. Questionnaires

    1. Change in behavioral physical activity measured using a weekly questionnaire and compared at baseline and post-intervention
    2. 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
    3. Change in physical activity measured using a weekly questionnaire and compared at baseline and post-intervention

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2022
  2. Study start21 Nov 2020
  3. Primary completion6 Jun 2022
  4. Study completion6 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668442
Sponsor's protocol ID
H-21062951
Status last verified
Dec 2022
First submitted
18 Nov 2022
Last updated
3 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If the data can be fully anonymized the data can be shared

Publications

  • 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.

    PubMed 36833589

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes and Type2diabetes, run by Mathias Ried-Larsen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Research Progression Criteria (time frame: 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2023.

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