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.
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
24
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.
Center for Physical Activity Research
Copenhagen, København N, Denmark
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
Time frame: 8 weeks
Participant Recruitment
Evaluation of participant recruitment was made by calculating number of participants recruited within three months.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 weeks
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
Time frame: 8 weeks
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