HOme-Based Exercise for Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— HOtBED  

Official title:

The Effects of HOme-Based Combined Exercise on Glycaemic Control and Anthropometric Measurements in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03103126
• Other study ID #: HOtBED
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2020
• Source: University of Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Combined resistance exercise and walking
Combined resistance exercise and walking

Locations

Country	Name	City	State
United Kingdom	Andrew Scott	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Portsmouth	Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period	Insulin sensitivity will be calculated from plasma glucose and serum insulin measures	6 weeks
Secondary	The effects of HBCE on body mass index (BMI) compared to physical activity advice during the 6 week study period	Height and body mass will be measured to determine whether the intervention improves BMI (kg.m2)	6 weeks
Secondary	The effects of HBCE on waist circumference compared to physical activity advice during the 6 week study period	To determine whether the intervention improves waist circumference in centimetres	6 weeks
Secondary	The effects of HBCE on body fat percentage compared to physical activity advice during the 6 week study period	To determine whether the intervention improves body fat percentage using bioelectrical impedance analysis	6 weeks
Secondary	The effect of HBCE on physical activity levels compared to physical activity advice during the 6 week study period	To determine if HBCE is more effective at increasing physical activity compared to physical activity advice using an International Physical Activity Questionnaire at baseline and the last week of the study period.	6 weeks
Secondary	The effect of HBCE on fitness compared to physical activity advice during the 6 week study period	To determine if HBCE is more effective at increasing fitness levels compared to physical activity advice using the Tecumseh step test, a modified version of the Harvard step test (Shorter test period and shorter step).	6 weeks
Secondary	The number of participants recruited and the average number per week	Can sufficient participant numbers can be recruited from a DESMOND day? The number of participants recruited and average per week of recruitment will be recorded and calculated.	6 weeks
Secondary	The percentage adherence to the home-based combined exercise programme	Adherence to the home-based combined exercise programme will be monitored in a diary	6 weeks
Secondary	Self-perceived health status measured using the SF-36 quality of life scale	The SF36 will be applied at baseline and post-intervention in both groups to determine any changes and differences between control vs exercise groups	6 weeks
Secondary	Self-efficacy to regulate exercise scale	The self-efficacy to regulate exercise scale will be applied at baseline and post-intervention in both groups to determine any changes and differences between control vs exercise groups	6 weeks