HOme-Based Exercise for Patients With Type 2 Diabetes (HOtBED)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Combined resistance exercise and walking

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO1 2ER
      • Andrew Scott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care.
Experimental: Combined resistance exercise and walking; Combined resistance exercise and walking.	Behavioral: Combined resistance exercise and walking; Combined resistance exercise and walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Portsmouth
• Collaborators: Portsmouth Hospitals NHS Trust
• Investigators: Study Chair: Andrew T Scott, PhD, University of Portsmouth

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: resistance exercise; pedometer-determined walking
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HOtBED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be stored in link-anonymised form and will not be made available outside of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No