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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Combined resistance exercise and walking
Sponsored by
University of Portsmouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring pedometer-determined walking, resistance exercise

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Andrew Scott

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Combined resistance exercise and walking

Arm Description

Standard care.

Combined resistance exercise and walking.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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
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
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.
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).
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.
The percentage adherence to the home-based combined exercise programme
Adherence to the home-based combined exercise programme will be monitored in a diary
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
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

Full Information

First Posted
March 20, 2017
Last Updated
March 24, 2020
Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03103126
Brief Title
HOme-Based Exercise for Patients With Type 2 Diabetes
Acronym
HOtBED
Official Title
The Effects of HOme-Based Combined Exercise on Glycaemic Control and Anthropometric Measurements in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants volunteered despite two recruitment rounds.
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Portsmouth
Collaborators
Portsmouth Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
pedometer-determined walking, resistance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial: control group vs. one intervention arm
Masking
Outcomes Assessor
Masking Description
The conditions/treatments cannot be masked but the outcome assessors will be masked as to the arm that the participants are allocated to.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care.
Arm Title
Combined resistance exercise and walking
Arm Type
Experimental
Arm Description
Combined resistance exercise and walking.
Intervention Type
Behavioral
Intervention Name(s)
Combined resistance exercise and walking
Intervention Description
Combined resistance exercise and walking
Primary Outcome Measure Information:
Title
The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period
Description
Insulin sensitivity will be calculated from plasma glucose and serum insulin measures
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The effects of HBCE on body mass index (BMI) compared to physical activity advice during the 6 week study period
Description
Height and body mass will be measured to determine whether the intervention improves BMI (kg.m2)
Time Frame
6 weeks
Title
The effects of HBCE on waist circumference compared to physical activity advice during the 6 week study period
Description
To determine whether the intervention improves waist circumference in centimetres
Time Frame
6 weeks
Title
The effects of HBCE on body fat percentage compared to physical activity advice during the 6 week study period
Description
To determine whether the intervention improves body fat percentage using bioelectrical impedance analysis
Time Frame
6 weeks
Title
The effect of HBCE on physical activity levels compared to physical activity advice during the 6 week study period
Description
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.
Time Frame
6 weeks
Title
The effect of HBCE on fitness compared to physical activity advice during the 6 week study period
Description
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).
Time Frame
6 weeks
Title
The number of participants recruited and the average number per week
Description
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.
Time Frame
6 weeks
Title
The percentage adherence to the home-based combined exercise programme
Description
Adherence to the home-based combined exercise programme will be monitored in a diary
Time Frame
6 weeks
Title
Self-perceived health status measured using the SF-36 quality of life scale
Description
The SF36 will be applied at baseline and post-intervention in both groups to determine any changes and differences between control vs exercise groups
Time Frame
6 weeks
Title
Self-efficacy to regulate exercise scale
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender is not an eligibility or outcome measure so self-representation will suffice as an indicator
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Scott, PhD
Organizational Affiliation
University of Portsmouth
Official's Role
Study Chair
Facility Information:
Facility Name
Andrew Scott
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO1 2ER
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be stored in link-anonymised form and will not be made available outside of the research team.

Learn more about this trial

HOme-Based Exercise for Patients With Type 2 Diabetes

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