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The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study

The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000379718
Acronym
GREAT
Enrollment
16
Registered
2022-03-04
Start date
2022-04-22
Completion date
2023-09-29
Last updated
2024-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Almost 1million Australian adults (5.3% of the population aged over 18years) have type 2 diabetes (T2D). The benefits of exercise for people with T2D include improved glycaemic control, reduced body fat, increased fitness, and reduced pain. These benefits can be observed even with once weekly supervised sessions. Medicare subsidises eight group exercise classes annually for people with T2D. However, barriers such as lack of transport, financial cost and living in regional centres can preclude people from participating in-person. Telehealth may be an alternative approach to overcome these barriers. In response to COVID-19, Medicare are now subsidising one-on-one videoconference exercise services; this funding has not been extended to group services. In people with T2D, being physically active with others is an important motivator; specifically, the accountability, increased enjoyment, and sense of community that accompanies group training improves adherence, which ultimately improves health outcomes. The feasibility and efficacy of group services delivered via telehealth have not been evaluated in T2D, though a small study in liver transplant recipients has shown it to be an appropriate alternative to in-person services. Given the unique provision of care in T2D with the availability of subsidised group exercise sessions, investigating the application of telehealth in this context is crucial. Therefore, the aims of this study are to: 1. Establish the feasibility (i.e., practicality, recruitment, attendance, retention, safety, and acceptability) of delivering group exercise interventions via telehealth, compared with in-person, in people with T2D 2. Evaluate the preliminary efficacy of an 8week telehealth group exercise intervention on behavioural (physical activity levels) and clinical (bloods, body composition, physical function) outcomes, compared with an in-person group intervention, in people with T2D 3. Evaluate the impact of the mode of service delivery on behavioural and clinical outcomes 16weeks following an 8week group exercise intervention in people with T2D 4. Determine the validity and reliability of in-person clinician-measured versus telehealth-supervised participant self-measured assessments

Interventions

Potential participants will initially make content via email or phone if they are willing to volunteer to take part in the study. Potential participants will initially be screened to ensure they meet all eligibility criteria. After providing written informed consent, the participants will attend the baseline assessment session at the University. Within 72 hours of this session, they will be asked to repeat tests in their home environment, while being supervised by an Accredited Exercise Physiolo

Potential participants will initially make content via email or phone if they are willing to volunteer to take part in the study. Potential participants will initially be screened to ensure they meet all eligibility criteria. After providing written informed consent, the participants will attend the baseline assessment session at the University. Within 72 hours of this session, they will be asked to repeat tests in their home environment, while being supervised by an Accredited Exercise Physiologist via telehealth. The 8-week telehealth exercise program will be delivered in groups of five by an Accredited Exercise Physiologist using Zoom, including two-way audio-visual communication. Each session will be 1 hour and will occur once weekly – 45 minutes will be dedicated to the exercise program and 15 minutes to education. Each 45-minute exercise program will include both aerobic and resistance training, following the Exercise and Sports Science Australia guidelines for people with type 2 diabetes (i.e., moderate to vigorous intensity, assessed by Borg RPE scale). The exercises will be selected based on the availability of equipment/space and individual participant needs within the group; examples may include squats, push-ups, banded rows, and/or balance exercises. Adherence will be monitored through attendance checklists. The sessions will occur once weekly, though participants will be provided with additional resources for completing self-directed exercise external to the supervised sessions (e.g., Exercise and Sports Science Australia Exercise Right at Home website). The frequency, intensity, duration and mode of self-directed exercise will be at the discretion of the participants, and will not be monitored. In addition to the structured exercise component, the program will also include 15 minutes of education to help participants transition to self-management. These will be delivered by electronic slide presentations at the end of each session, and will cover such topics as health behaviour change, exercise guidelines for T2D, goal setting, medications, and dietary guidelines. To enhance the likelihood of long-term behaviour change, the education sessions will target key constructs from Bandura’s Social Cognitive Theory (i.e., self-efficacy, goals, beliefs, and social support). After the 8-week program, all participants will attend the University for a final assessment session.

Sponsors

Dr Emily Cox
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Participants will require a glycated haemoglobin (HbA1c) level of greater than or equal to 7.0% at baseline, and access to a device with a camera (e.g., computer/laptop/tablet). Potential participants will be screened using the Adult Pre-Exercise Screening System to ensure safety.

Exclusion criteria

People will be ineligible if they have any condition as per the absolute contraindications to exercise outlined by the American College of Sports Medicine8 including, but not limited to: unstable angina; recent (within the past four weeks) myocardial infarction; coronary artery disease; uncompensated heart failure; New York Heart Association functional classification II-IV; severe valvular illness; pulmonary disease; uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg); renal failure (chronic kidney disease stages IV-V); cardiomyopathy. People will also be ineligible for: having type 1 diabetes, meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), planned medical operations during the research period, a physical condition whereby exercise training would be inappropriate, pregnant or expecting to be pregnant during the study period, non-English speaking, and cognitive impairment that limits the ability to understand verbal instructions.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026