Home » Trials » SLCTR/2016/017
The effects of supervised progressive resistance exercise training compared to aerobic exercise training on behavioral, anthropometry, physical fitness, appetite, blood glucose control and selected biochemical parameters in Sri Lankan adults with type 2 diabetes mellitus
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SLCTR Registration Number
SLCTR/2016/017
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effects of supervised progressive resistance exercise training compared to aerobic exercise training on behavioral, anthropometry, physical fitness, appetite, blood glucose control and selected biochemical parameters in Sri Lankan adults with type 2 diabetes mellitus
Public Title of Trial
Sri Lanka Diabetes Aerobic and Resistance Training Study
Disease or Health Condition(s) Studied
Type 2 diabetes mellitus
Scientific Acronym
None
Public Acronym
SL-DARTS
Brief title
Sri Lanka Diabetes Aerobic and Resistance Training Study
Universal Trial Number
U1111-1181-7561
Any other number(s) assigned to the trial and issuing authority
ERC (Colombo): EC-14-071
What is the research question being addressed?
Is there a difference between supervised resistance training and aerobic training on glycosylated hemoglobin (HbA1c) levels and body fat, in Sri Lankan adults with type 2 diabetes mellitus?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The intervention will be conducted at the University of Colombo, Sri Lanka (Gymnasium and Allied Health Sciences Unit Faculty of Medicine).
The study will have 2 intervention groups (A, B) and a control (C) group. Participants will be recruited in a roll-in method and allocated to each group using covariate-adaptive randomization.
Participants of Group A will undergo an individually supervised progressive resistance exercise program. Exercise sessions lasting 60-75 minutes will take place twice a week for a total of 12 weeks.
Participants of Group B will undergo an individually supervised progressive aerobic exercise program. Exercise sessions lasting 60-75 minutes will take place twice a week for a total of 12 weeks.
The control will not have any exercise program but will receive standard treatment of medications and nutritional advice.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline, and at the end of 12 weeks (following 24 exercise sessions). ] |
Secondary outcome(s)
|
1.
|
[ Outcomes 1-7 will be assessed at baseline and at the end of the 12 weeks of intervention. Outcome 8 will be assessed pre-and post-exercise session at baseline and at the final session (end of 12 weeks). ] |
Target number/sample size
90 (30 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-08-01
Anticipated end date
2017-12-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University Grants Commission Sri Lanka: UGC/DRIC/QUT 2014/CMB/01 ; University of Colombo: AP/3/2/2015/PG/04
Regulatory approvals
Status
Approved
Date of Approval
2014-07-24
Approval number
14-071
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800, Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dilip Chathuranga Ranasinghe
Lecturer
Allied Health Sciences Unit
Faculty of Medicine, University of Colombo
No. 25, Kynsey Road, Colombo 0800
Sri Lanka
Current PhD Candidate at
School of Exercise and Nutrition Sciences
& Institute of Health and Biomedical Innovation
Queensland University of Technology
Q Block,4WS12,Kelvin Grove, Qld 4059, Brisbane Australia.
Tel: 0094-112-688686
Mob: 0094-773-707016
chath_r@yahoo.com.au; dc.ranasinghe@hdr.qut.edu.au
Contact Person for Public Queries
Dr Prasad Katulanda
Senior Lecturer and Honorary Consultant Endocrinologist/Diabetologist
Department of Clinical Medicine
Faculty of Medicine, University of Colombo,
No. 25, Kynsey Road, Colombo 0800
Sri Lanka
Tel: 00 94-112-679204
Mob: 00 94-772-920991
prasad.katulanda@yahoo.com
Primary study sponsor/organization
University Grants Commission
University Grants Commission
No. 20, Ward Place, Colombo 7
Sri Lanka
Tel: +94 11 3092449, +94 11 2695301
gayaniugc@gmail.com
http://www.ugc.ac.lk/
Secondary study sponsor (If any)
University of Colombo
Kumaratunga Munidasa Mawatha, Colombo
Sri Lanka
Tel: 0112 586712
acpbuoc@gmail.com
http://www.cmb.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
