Clinical trial NCT03103126: HOme-Based Exercise for Patients With Type 2 Diabetes
Official title: The Effects of HOme-Based Combined Exercise on Glycaemic Control and Anthropometric Measurements in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: pedometer-determined walking
resistance exercise
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
Collaborators: name: Portsmouth Hospitals NHS Trust
First posted: 2017-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial: control group vs. one intervention arm
Primary purpose: TREATMENT

Brief summary: The study aims to investigate whether 12 weeks of structured aerobic and resistance exercises completed at home can have a beneficial effect on the health of patients with type 2 diabetes compared to standard physical activity advice. The study will investigate whether the exercises can reduce factors such as patient's BMI, blood pressure and waist circumference, as well as blood glucose and insulin sensitivity. Participants will use pedometers and Therabands to carry out their exercises.

This will be compared to giving participants a physical activity advice sheet and no structured exercise examples.

Detailed description: The study will be a 12 week randomised controlled trial, so that the researchers can isolate the independent variable of home-based combined exercise to ensure that factor is affecting the patient's measurements. Participants will be recruited from a DESMOND day through the medical team informing them of the study via a Participant Information Sheet. Once recruited and informed consent is obtained, the participants will be assigned an ID number so that they can remain anonymous, and then will be randomly allocated into either the exercise or control group. Ideally 9 participants will be recruited into each group.

All participants will be invited into the Spinnaker Physiology Laboratory at Portsmouth University at a specified date. They will have their health and fitness data collected and complete a 7-day physical activity recall questionnaire, SF-36 Form and Self-Efficacy Questionnaire before and after the intervention period to measure any change in their PA levels, self-perceived health status and self-efficacy towards exercise. They will be provided with a 7 day food diary to complete.

A control group is included so that the researchers can rule out other factors that may affect glycaemic control and anthropometric measurements. The control group will be given a Physical Activity Advice sheets as this mimics what they would normally have access to through DESMOND. The control group will receive a Physical Activity advice sheet and the researchers will talk through the advice sheet with the participants. If the control group were to have no intervention, this would be less than they normally have access to as part of their normal diabetes treatment.

The exercise group will be given the therabands and pedometer, a Physical Activity Log, Pedometer log, theraband protocol and Physical Activity Advice sheet, which will all be explained to the participant. All theraband exercises will be performed so that the researchers can ensure the participant has a good technique. The exercise intervention resistance segment will involve the exercise group performing 7 theraband exercises on three days per week on non-consecutive days. For the aerobic exercise, the participants will be asked to use the provided pedometer to record the number of steps they complete on day 1 of the intervention (assuming that on this day, they complete their normal daily activities that they would do most days of the week). They then are asked to add 2,000 steps onto their daily steps; this amount will then become their daily step goal. Once they have reached this goal on 4 out of 5 days, they are asked to increase their step goal by 500.

The participants will be invited back after 12 weeks to repeat the pre-study measures to assess any changes.

Eligibility criteria: Inclusion Criteria:

* Participants must not be meeting the government's recommended physical activity guideline (150 min moderate intensity exercise per week)
* Must be 18 years of age or over
* Diagnosed with Type 2 Diabetes and have been referred to DESMOND, as this is where they will be recruited from.

Exclusion Criteria:

● Co-morbidity that prevents them undertaking physical activity safely, such as cardiac disease or pulmonary disease or significant musculoskeletal limitations. This will be determined from the Exercise and Health History Questionnaire. If their diabetes is severe and they have peripheral neuropathy or any associated systemic, cardiovascular, metabolic or musculoskeletal problems which will inhibit their ability to perform exercise safely.

Primary outcomes:
measure: The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
Secondary outcomes:
measure: The effects of HBCE on body mass index (BMI) compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
measure: The effects of HBCE on waist circumference compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
measure: The effects of HBCE on body fat percentage compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
measure: The effect of HBCE on physical activity levels compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
measure: The effect of HBCE on fitness compared to physical activity advice during the 6 week study period
timeFrame: 6 weeks
measure: The number of participants recruited and the average number per week
timeFrame: 6 weeks
measure: The percentage adherence to the home-based combined exercise programme
timeFrame: 6 weeks
measure: Self-perceived health status measured using the SF-36 quality of life scale
timeFrame: 6 weeks
measure: Self-efficacy to regulate exercise scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Andrew Scott
state: Hampshire
Study officials:
affiliation: University of Portsmouth
name: Andrew T Scott, PhD
role: STUDY_CHAIR
References: