ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000505808

Ethics application status

Approved

Date submitted

8/03/2021

Date registered

30/04/2021

Date last updated

16/02/2023

Date data sharing statement initially provided

30/04/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Diabetes Clinic: Exercise Physiology group service for older people with type 2 diabetes

Scientific title

Diabetes Clinic: Feasibility and acceptability on an Exercise Physiology group service for older people with type 2 diabetes

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1262-5251

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Diabetes Clinic project aims to examine the feasibility, acceptability and preliminary efficacy of an Accredited Exercise Physiologist (AEP) delivered type 2 diabetes (T2D) group service for older adults. The Diabetes Clinic will be delivered within the UNSW Medicine Lifestyle Clinic, as part of usual clinical service, with the aim of improving diabetes management through increased participation in healthy lifestyle behaviours including exercise. Participants may choose to participate in Part A and/or Part B. Furthermore, those who are not involved in Part A are still eligible to participate in Part B.

The project will have an initial focus group (PART A) conducted 1 month prior to the start of the Diabetes Clinic intervention (PART B). A full qualitative analysis of the information collected in PART A will not be undertaken. Instead, it aims to inform on key logistical aspects of the protocol (e.g. morning vs afternoon sessions, frequency per week, duration of sessions, patient goals, exercise preference, enablers and barriers to attending). Any feedback that is deemed by the research team to warrant a modification of the intended protocol, as is presented in this submission, will be implemented, but only following ethical approval after the modification has been submitted and reviewed. This will be done prior to the commencement of PART B data collection. Part B Focus group will then be conducted at the completion on the group intervention, using quantitative analysis to examine feasibility, acceptability, and impact on health outcomes. Both Part A and Part B Focus groups will go for 45-60 minutes each. The focus groups will be facilitated by two researchers, at least one of whom is an AEP with a minimum of 5 years experience. The focus groups will be conducted online via Microsoft Teams, at a place and time convenient for the participant (e.g. their home). If the participant does not have online access, they may be invited to attend the focus group from an available space within the UNSW Medicine Lifestyle Clinic. If participants do need to attend face-to-face, all necessary social distancing requirements will be adhered to.

PART B: The Diabetes Clinic will be delivered face to face within the UNSW Medicine Lifestyle Clinic (UNSW Sydney Australia) by AEPs with a minimum 5 years experience, as part of usual clinical service, with the aim of improving diabetes management through increased participation in healthy lifestyle behaviours including exercise. The group will have a minimum of 2 and maximum of 12 participants. If there are more than 12 participants enrolled at any one time, a second group will be created to accommodate numbers.

The group services will be delivered as a rolling program, with a group session being delivered once a week to facilitate participant adherence. Following initial assessment (90-120 minutes including health interview, physical assessment and questionnaire completion), each participant will receive 8 sessions at a frequency of once per week. Each session will run between 60-90 minutes to include both and educational (approximately 30 minutes) and exercise (approximately 60 minutes) component.

The educational component will be delivered in Sessions 1-8, ensuring each participant has exposure to all topics irrespective of when they commence the group services. The below topics will be discussed across the 8 sessions with the use of educational material developed by Diabetes Australia, Heart foundation Australia and the Australian Government department of health.

Session 1: Understanding Type 2 Diabetes (fact sheet understanding type2 diabetes)
Session 2: Managing Diabetes as you age (booklet managing diabetes as you age guide for people over 65)
Session 3: Health Care team guide for people over 65 (booklet your health care team guide for people over 65)
Session 4: Physical Activity for diabetes (fact sheet physical activity, physical activity action plan)
Session 5: Diabetes related complications; Strategies for optimal heart health (fact sheet diabetes related complications)
Session 6: Healthy eating guide for people over 65 (booklet healthy eating guide for people over 65, Health weight action plan)
Session 7: Adjusting to life with diabetes (fact sheet adjusting to life with diabetes, Psychological and social health action plan)
Session 8: Physical activity tips and ideas (Choose health brochure, Aus Gov PA tips and ideas older adults)

The exercise component will be evidence based and delivered utilising the variety of exercise equipment available within the UNSW Medicine Lifestyle Clinic. A combination of aerobic, resistance, balance and flexibility exercises will be prescribed as is suitable and relevant to the participant within the group setting. The below exercise prescription guidelines as per American College of Sports Medicine (ACSM) will be followed:

Exercise:
AEROBIC EXERCISE
Frequency 1xwk
Intensity Light-Vigorous (Light: 40-55% HRmax, RPE 8-10; Moderate 55-70%HRmax, RPE 11-13; Vigorous 70-90%HRmax, RPE 14-16)
Time 20-30 minutes
Type Major muscle groups: Cycling (upright/recumbent); Walking (treadmill), rowing, stepping
Volume Aerobic exercise: Frequency x intensity x time
Pattern One continuous bout or multiple bouts (e.g. 30 minutes or 3 x 10 min)
Progression Commence first exercise session in wk 1 at low-moderate intensity (50-60%HRmax, RPE 9-13) and progress gradually as tolerated by the individual

RESISTANCE EXERCISE
Frequency 1xwk
Intensity Light-Vigorous (Light: 30-49%1RM, RPE 9-11; Moderate 50-69%1RM, RPE: 12-13; Vigorous: 70-84%1RM, RPE 14-17)
Time 20-30 minutes
Type Pin-loaded weight plate machined (e.g. Leg Press, Leg Extension, Leg Curl, Seated row, Chest Press, Lat Pulldown) body weight, free weights, therabands.
Sets 1-3
Repetitions 8-12
Volume sets x reps x days
Pattern 2 second concentric, 3 second eccentric. 1-2 minute rest between sets
Progression Commence first exercise session in wk 1 at low-moderate intensity (50-69%1RM, RPE 9-13) and progress gradually as tolerated by the individual

Balance and flexibility exercises will be prescribed and delivered as determined to be suitable to the individuals attending the group. Participants attendance and physical activity enjoyment will be recorded each session. All prescriptive elements of all exercises performed will be recorded on pre-prepared program training sheets by the supervising AEP and supporting 4th year Exercise Physiology undergraduate students each session to ensure all necessary detail is captured.

The final assessment will be completed on the week following the completion of their eighth group session. To account for a real-world setting, the final assessment may be conducted up to 2 weeks after attending their eighth and final group session. The total time commitment for attending the assessments and group sessions is 16 hours over approximately 10 weeks. The 6 month follow up would include another 90-120 minute assessment. PART B Focus groups will be conducted within 1 month of participants completing their final assessment and with a minimum of 2 participants (no maximum).

Intervention code [1]

Lifestyle

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility outcomes will be examined in terms of session attendance frequencies. This will also be reported as a percentage of total attendance. This outcome will be assessed using a session attendance log. Criteria for success will be attendance greater than or equal to 5 out of the 8 group sessions.

Timepoint [1]

Assessed at the final assessment (No greater than 2 weeks following the completion of the eighth group session).

Primary outcome [2]

Feasibility
Feasibility outcomes will be examined in terms of session compliance. This outcome will be assessed using exercise session program sheets.

Timepoint [2]

Assessed at the completion of the eighth group session (week 8).

Primary outcome [3]

Acceptability
Participants’ perspectives on the intervention’s acceptability will be based on feedback captured in the exiting Patient experience questionnaire and in the PART B focus groups. Acceptability will encompass what participants liked most/least about the treatment and their suggestions for the content and format of the sessions.

Timepoint [3]

Assessed post intervention (Part B Focus group - no greater than 4 weeks following the completion of the final assessment).

Secondary outcome [1]

Body Mass Index (BMI)
Weight will be measured using a digital scale with the person fasting, barefoot and dressed only in underwear and a surgical gown. The gown will be weighed and the weight of which will be subtracted from the person's body weight. Height will be measured using a SECA wall mounted stadiometer with the person barefoot and in the hospital gown. BMI will then be calculated using the following formula: weight (kg) divided by height (in metres) squared.

Timepoint [1]

BMI will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).

Secondary outcome [2]

Waist Circumference.
Waist circumference will be measured in cm according to International Diabetes Federation/American Heart Association (IDF/AHA) guidelines, midway between the lowest ribs and the iliac crest.

Timepoint [2]

Waist circumference will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).

Secondary outcome [3]

Blood Pressure.
Resting blood pressure will be assessed via a validated automated sphygmomanometer.

Timepoint [3]

Resting blood pressure will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..
It will also be assessed as an outcome at 3 time points: baseline (week -1), midway through the intervention (week 4) and at the end of the intervention (week 8).
Resting blood pressure will also be will be measured and recorded prior to each exercise session to ensure participant safety.

Secondary outcome [4]

Functional exercise capacity
Functional exercise capacity, measured as total meters covered, will be assessed during the 6 minute walk test. The participant will walk as many laps as they can over a predetermined track within 6 minutes, with continuous heart rate and Rate of Perceived Exertion (RPE) monitoring (recorded every minute) by an AEP.

Timepoint [4]

Functional exercise capacity will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..

Secondary outcome [5]

Muscle strength
The difference in muscle strength at initial assessment compared to the final assessment. Lower limb muscular strength will be assessed via a 1 repetition maximum (RM) leg press and/or knee extension and/or leg curl on a pin-loaded machine, with maximum loads lifted added together for lower limb strength. Upper limb strength will be assessed via a 1RM seated row and/or chest press and/or lat pulldown pin-loaded machine, with maximum loads lifted added together for upper body strength. This is a composite primary outcome of whole body strength, which will be calculated by adding the lower body and upper body 1RM strength measures together.

Timepoint [5]

Whole body muscle strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..

Measurements will also be repeated fortnightly for progression of the intervention, but these measures won’t be used as outcomes.

Secondary outcome [6]

Handgrip strength
The difference in handgrip strength between groups at the end of the intervention period. This be assessed using a handgrip dynamometer.

Timepoint [6]

Handgrip strength will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..

Secondary outcome [7]

Cardiovascular Disease risk will be calculated using the ASCVD Risk Estimator Plus (http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) will be used to estimate patient’s 10-year ASCVD risk. The calculator uses the following information: Current Age (years), Sex (male/female), Race (White/African American/Other), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Total Cholesterol (mg/dL), HDL Cholesterol (mg/dL), LDL Cholesterol (mg/dL), History of Diabetes (Yes/No), Smoker (Current/Former/Never), On Hypertension Treatment (Yes/No), On a Statin (Yes/No) and On Aspirin Therapy (Yes/No).

Timepoint [7]

ASCVD Risk will be calculated at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session)..

Secondary outcome [8]

Perceived Physical Activity
The Active Australia Survey will be used to assess perceived participation in various types of physical activity as well as establishing awareness of current public health messages about physical activity.

Timepoint [8]

Active Australia Survey will be assessed at 2 time points: Initial Assessment and Final Assessment (no greater than 2 weeks following the completion of the eighth group session).

Secondary outcome [9]

Quality of life
Quality of life (as a composite of all 8 sub scales of physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) will be assessed using the Short Form (SF)36 v2 Survey.

Timepoint [9]