Diabetes Mellitus, Type 2NCT01638351
Resistance Training in Diabetic Elder Patients
A study testing Resistance exercise in people with Diabetes Mellitus, Type 2, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Oct 2012
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years old or older
- no clinical diagnosis of cardiovascular disease
- patients with or without type 2 diabetes mellitus
Who cannot join
- glycated hemoglobin > 10%
- pulmonary disease
- cancer
- cognitive dysfunction
- any neurological or musculoskeletal disease that will affect exercise performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus
The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Resistance exercise, Usual care
- Keywords
- Diabetes mellitus, Resistance exercise, Elderly, Skeletal muscle dysfunction, Metabolomics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
Progressive resistance exercise training, 3 times a week for 12 weeks.
Usual careBehavioural
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level. Receives: Behavioral: Usual care |
| Resistance exercise | Experimental | Progressive resistance training, 3 times a week for 12 weeks Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal muscle strength
This outcome measure includes upper and lower body maximal muscle strength.
Measured: Twelve weeks
Secondary outcomes (7)
Physical body function
This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.
Measured: Twelve weeks
Quality of life
This outcome measure will be assessed by the diabetes-specific questionnaire.
Measured: Twelve weeks
Waist circumference
Measured: Twelve weeks
Body mass index
This outcome measure includes the measurements of body height and body weight.
Measured: Twelve weeks
Functional capacity
Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.
Measured: Twelve weeks
Blood biochemical parameters
This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.
Measured: Twevle weeks
Muscle oxygenation
Muscle oxygenation will be assessed during exercise
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Tai Wu, Ph.D., Study chair, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638351
- Sponsor's protocol ID
- 201110029RC
- Status last verified
- Nov 2012
- First submitted
- 8 Jul 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
PubMed 12453982Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
PubMed 12351469Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.
PubMed 12902533Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.
PubMed 19157617
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01638351
- Acronym / sponsor ID
- 201110029RC
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes mellitus, Resistance exercise, Elderly, Skeletal muscle dysfunction, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Jul 2012 (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.
The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual careParticipants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level. |
| Resistance exercise | Experimental | Behavioral: Resistance exerciseProgressive resistance training, 3 times a week for 12 weeks |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years old or older
- no clinical diagnosis of cardiovascular disease
- patients with or without type 2 diabetes mellitus
Key exclusion criteria (5 listed)
- glycated hemoglobin > 10%
- pulmonary disease
- cancer
- cognitive dysfunction
- any neurological or musculoskeletal disease that will affect exercise performance
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 exerciseProgressive resistance exercise training, 3 times a week for 12 weeks. | Behavioural | Resistance exercise |
| Usual careParticipants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level. | Behavioural | Usual care |
Primary outcome
Maximal muscle strength
Time frame: Twelve weeks
This outcome measure includes upper and lower body maximal muscle strength.
7 secondary outcomes
Physical body function
Time frame: Twelve weeks
Quality of life
Time frame: Twelve weeks
Waist circumference
Time frame: Twelve weeks
Body mass index
Time frame: Twelve weeks
Functional capacity
Time frame: Twelve weeks
Blood biochemical parameters
Time frame: Twevle weeks
Muscle oxygenation
Time frame: Twelve weeks
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 16 Nov 2012.
- Background: PubMed 12453982Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
- Background: PubMed 12351469Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
- Background: PubMed 12902533Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.
- Background: PubMed 19157617Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.
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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.
Ying-Tai Wu, Ph.D. study chair
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Diabetes Mellitus, Type 2, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 16 Nov 2012. 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 Taiwan. 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 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?
Maximal muscle strength (time frame: Twelve weeks). 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 NCT01638351, which also lists 4 linked publications.
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 16 Nov 2012.