Type 2 Diabetes MellitusNCT03280758
Muscle Strength Training for Older Adults With Type II Diabetes
A study testing Muscle Strengthening exercises in people with Type 2 Diabetes Mellitus, run by The University of Hong Kong.
Trial summary
This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM). Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Muscle Strengthening exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 30 Aug 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2 DM
- 60-75 years old
- ability to perform exercise
Who cannot join
- Advanced hypertension (≥ 160/100 mm Hg)
- severe obesity (BMI ≥ 48kg/m2)
- insulin pump user
- coronary heart disease history
- chronic obstructive pulmonary disease
- advanced neuropathy
Show all 9Show fewer
- learning or mental disorder, or
- any other diseases that prevent subjects from exercising safely.
- Those who participate in regular resistance or aerobic exercises will also be excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial
This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).
60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.
Read more
Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).
The control group will not receive any training but can continue usual medical care and daily activities.
Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).
Read the detailed description
This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).
This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.
Information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).
The control group will not receive any training but can continue usual medical care and daily activities.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Muscle Strengthening exercises
- Keywords
- Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function
- 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.
Muscle Strengthening exercisesBehavioural
Participants will be required to participate in resistance training 3 hours per week.
| Study group | Role | What they receive |
|---|---|---|
| Muscle strengthening group | Experimental | Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer. Receives: Behavioral: Muscle Strengthening exercises |
| Control group | No intervention | No exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose level
Measured: 4 months
Lipid profiles
HDL, LDL, Trig
Measured: 4 months
Secondary outcomes (3)
Muscle strength
Whole body
Measured: 4 months
Muscle mass
Whole body
Measured: 4 months
Functional performance
Walking ability
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Jan 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley S.M. Fong, The University of Hong Kong
- Investigators
- Siu Ming Fong, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280758
- Sponsor's protocol ID
- 02
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.
PubMed 21705072Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.
PubMed 23537893Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.
PubMed 24420336Dunstan 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 12351469American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
PubMed 12017678Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
PubMed 10912903Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.
PubMed 20093961Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
PubMed 12905089
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03280758
- Acronym / sponsor ID
- 02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 12 Sep 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.
This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).
60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.
Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).
The control group will not receive any training but can continue usual medical care and daily activities.
Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).
Detailed description
This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM).
This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group.
Information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session).
The control group will not receive any training but can continue usual medical care and daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle strengthening group | Experimental | Behavioral: Muscle Strengthening exercisesParticipants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer. |
| Control group | No intervention | –No exercise training. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- T2 DM
- 60-75 years old
- ability to perform exercise
Key exclusion criteria (9 listed)
- Advanced hypertension (≥ 160/100 mm Hg)
- severe obesity (BMI ≥ 48kg/m2)
- insulin pump user
- coronary heart disease history
- chronic obstructive pulmonary disease
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 |
|---|---|---|
| Muscle Strengthening exercisesParticipants will be required to participate in resistance training 3 hours per week. | Behavioural | Muscle strengthening group |
Primary outcome
Fasting glucose level
Time frame: 4 months
Lipid profiles
Time frame: 4 months
HDL, LDL, Trig
3 secondary outcomes
Muscle strength
Time frame: 4 months
Muscle mass
Time frame: 4 months
Functional performance
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Background: PubMed 21705072Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.
- Background: PubMed 23537893Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.
- Background: PubMed 24420336Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.
- 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 12017678American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
- Background: PubMed 10912903Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
- Background: PubMed 20093961Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.
- Background: PubMed 12905089Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
- Individual participant dataSharing planned: No
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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.
Siu Ming Fong, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Strengthening exercises in people with Type 2 Diabetes Mellitus, run by The University of Hong Kong.
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 9 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: status not confirmed, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siu Ming Fong, PhD (28315260, smfong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose level (time frame: 4 months). 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 NCT03280758, which also lists 8 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 12 Sep 2017.