Diabetes Mellitus, Type 2HOtBEDNCT03103126
HOme-Based Exercise for Patients With Type 2 Diabetes
A study testing Combined resistance exercise and walking in people with Diabetes Mellitus, Type 2, run by University of Portsmouth at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Combined resistance exercise and walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Combined resistance exercise and walking
- Keywords
- pedometer-determined walking, resistance exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined resistance exercise and walkingBehavioural
Combined resistance exercise and walking
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care. |
| Combined resistance exercise and walking | Experimental | Combined resistance exercise and walking. Receives: Behavioral: Combined resistance exercise and walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (9)
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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start1 May 2019
- Primary completion1 Jul 2019
- Study completion1 Sep 2019
Why it stopped: No participants volunteered despite two recruitment rounds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial: control group vs. one intervention arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Portsmouth
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Responsible party
- Principal investigator, Andrew Scott, University of Portsmouth
- Investigators
- Andrew T Scott, PhD, Study chair, University of Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103126
- Sponsor's protocol ID
- HOtBED
- Acronym
- HOtBED
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be stored in link-anonymised form and will not be made available outside of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of HOme-Based Combined Exercise on Glycaemic Control and Anthropometric Measurements in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03103126
- Acronym / sponsor ID
- HOtBED / HOtBED
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- pedometer-determined walking, resistance exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants volunteered despite two recruitment rounds.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PortsmouthUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial: control group vs. one intervention arm
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care. |
| Combined resistance exercise and walking | Experimental | Behavioral: Combined resistance exercise and walkingCombined resistance exercise and walking. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- ● 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined resistance exercise and walkingCombined resistance exercise and walking | Behavioural | Combined resistance exercise and walking |
Primary outcome
The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
Insulin sensitivity will be calculated from plasma glucose and serum insulin measures
9 secondary outcomes
The effects of HBCE on body mass index (BMI) compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
The effects of HBCE on waist circumference compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
The effects of HBCE on body fat percentage compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
The effect of HBCE on physical activity levels compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
The effect of HBCE on fitness compared to physical activity advice during the 6 week study period
Time frame: 6 weeks
The number of participants recruited and the average number per week
Time frame: 6 weeks
The percentage adherence to the home-based combined exercise programme
Time frame: 6 weeks
Self-perceived health status measured using the SF-36 quality of life scale
Time frame: 6 weeks
Self-efficacy to regulate exercise scale
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No. The data will be stored in link-anonymised form and will not be made available outside of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew T Scott, PhD study chair
University of Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined resistance exercise and walking in people with Diabetes Mellitus, Type 2, run by University of Portsmouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of home-based combined exercise on insulin sensitivity compared to physical activity advice during the 6 week study period (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.