DiabetesPhase 1NCT00221208
Home Based Resistance Training For Type 2 Diabetes
A Phase 1 study testing Resistance Training in people with Diabetes, run by University of Alberta at 1 site in Canada.
Trial summary
This study will investigate the biological and psychosocial benefits of a home-based resistance-training program for sedentary, obese adults living with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 1
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Overweight and Obese (BMI>28) Living inside of City limits
Who cannot join
- Ischemic heart disease Osteoporosis Musculoskeletal abnormalities Currently performing resistance training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Home Based Resistance Training Program for Obese Adults With Type 2 Diabetes
This study will investigate the biological and psychosocial benefits of a home-based resistance-training program for sedentary, obese adults living with type 2 diabetes.
Read the detailed description
Obese individuals with type 2 diabetes will be randomly assigned to either an experimental group where they will perform moderate to high intensity resistance training (50-60% 1RM weeks 1-3 and 70-85% 1RM in weeks 4-16) three times per week for 16 weeks or to a non-training control group. All resistance training will be performed at home using a multigym apparatus. A personal trainer (PT) will come to the homes of each participant in the experimental group to make sure that exercises are being performed safely with the correct technique, and at the prescribed intensity. In the first two weeks, the PT will come to all 3 sessions per week. In weeks 3-4 this will be reduced to 2 times per week, in weeks 5-8 the PT will come once per week and in the last 8 weeks once bi-weekly.
- Conditions
- Diabetes
- Being tested
- Resistance Training
- Keywords
- Diabetes, Resistance Training
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Muscular strength
Secondary outcomes (1)
Fasting blood glucose, insulin, lipid concentrations, C-reactive protein, body composition (DEXA), exercise adherence, behaviour change, psychosocial predictors of resistance training, quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Ron C Plotnikoff, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221208
- Sponsor's protocol ID
- OHP - 69441
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2024
- Results posted
- No
Publications
Plotnikoff RC, Eves N, Jung M, Sigal RJ, Padwal R, Karunamuni N. Multicomponent, home-based resistance training for obese adults with type 2 diabetes: a randomized controlled trial. Int J Obes (Lond). 2010 Dec;34(12):1733-41. doi: 10.1038/ijo.2010.109. Epub 2010 Jun 8.
PubMed 20531348
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home Based Resistance Training Program for Obese Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00221208
- Acronym / sponsor ID
- OHP - 69441
- Conditions
- Diabetes
- Keywords
- Diabetes, Resistance Training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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.
This study will investigate the biological and psychosocial benefits of a home-based resistance-training program for sedentary, obese adults living with type 2 diabetes.
Detailed description
Obese individuals with type 2 diabetes will be randomly assigned to either an experimental group where they will perform moderate to high intensity resistance training (50-60% 1RM weeks 1-3 and 70-85% 1RM in weeks 4-16) three times per week for 16 weeks or to a non-training control group. All resistance training will be performed at home using a multigym apparatus. A personal trainer (PT) will come to the homes of each participant in the experimental group to make sure that exercises are being performed safely with the correct technique, and at the prescribed intensity. In the first two weeks, the PT will come to all 3 sessions per week. In weeks 3-4 this will be reduced to 2 times per week, in weeks 5-8 the PT will come once per week and in the last 8 weeks once bi-weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes Overweight and Obese (BMI>28) Living inside of City limits
Key exclusion criteria (1 listed)
- Ischemic heart disease Osteoporosis Musculoskeletal abnormalities Currently performing resistance training
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 |
|---|---|---|
| Resistance Training | Behavioural | – |
Primary outcome
HbA1c
Muscular strength
1 secondary outcome
Fasting blood glucose, insulin, lipid concentrations, C-reactive protein, body composition (DEXA), exercise adherence, behaviour change, psychosocial predictors of resistance training, quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 20531348Plotnikoff RC, Eves N, Jung M, Sigal RJ, Padwal R, Karunamuni N. Multicomponent, home-based resistance training for obese adults with type 2 diabetes: a randomized controlled trial. Int J Obes (Lond). 2010 Dec;34(12):1733-41. doi: 10.1038/ijo.2010.109. Epub 2010 Jun 8.
Related trials for Diabetes
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
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.
Ron C Plotnikoff, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Resistance Training in people with Diabetes, run by University of Alberta at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 5 Nov 2024. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221208, which also lists 1 linked publication.
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 5 Nov 2024.