Type 2 Diabetes MellitusNCT02093702

Impact of Structured Physical Activity Education Delivery in Patients With Type 2 Diabetes Mellitus

A study testing Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach and Unstructured Physical Activity and Exercise Education in people with Type 2 Diabetes Mellitus, run by Royal Victoria Hospital, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach and Unstructured Physical Activity and Exercise Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteCanada
Study dates: Apr 2014to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Man or woman with type 2 diabetes
Ready to begin regular physical activity
Age equal to or greater than 18
Age equal to or less than 64.

Who cannot join

Any vascular disease
Exhibits symptoms of coronary artery disease (CAD)
History of losing balance because of dizziness
History of losing consciousness
Has a bone or joint problem that could be made worse by a change in physical activity
Pregnant
Has been excluded by the Patient's Physician for any other health-related reason not stated under these exclusion criteria.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Barrie and Community Family Health Team Diabetes Program
Barrie, Ontario, L4M 6L2

Other trials in Canada

About this study

Official title: Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c Levels, Blood Pressure, Lipid Profile, Body Mass Index, Waist Circumference, and Adherence to Canadian Diabetes Association Clinical Practice Guidelines Weekly Physical Activity Recommendations for Patients With Type 2 Diabetes Mellitus: A Pilot Study.

This study aims to assess whether a structured exercise program has an impact on the following determinants of the disease in type 2 diabetes: HbA1C, blood pressure, lipids, body mass index and waist circumference. It also aims to assess the compliance and retention of patients with type 2 diabetes in a structured exercise program.

Conditions: Type 2 Diabetes Mellitus
Being tested: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach, Unstructured Physical Activity and Exercise Education
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.

Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness CoachBehavioural
Unstructured Physical Activity and Exercise EducationBehavioural

Study groups in NCT02093702
Study group	Role	What they receive
Unstructured Physical Activity and Exercise Education Delivery	Active comparator	50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator. Receives: Behavioral: Unstructured Physical Activity and Exercise Education
Structured Physical Activity and Exercise Education Delivery	Experimental	50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities. Receives: Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Hemoglobin A1c (HbA1c) Levels
Measured: Baseline and 12 months
Mean Change in Systolic Blood Pressure
Measured: Baseline and 12 months
Mean Change in Waist Circumference
Measured: Baseline and 12 months
Mean Change in Body Mass Index
Measured: Baseline and 12 months
Mean Change in Serum Total Cholesterol
Measured: Baseline and 12 months
Mean Change in HDL-C
Measured: Baseline and 12 months
Mean Change in LDL-C
Measured: Baseline and 12 months
Mean Change in Triglycerides (TGs)
Measured: Baseline and 12 months
Mean Change in Total Cholesterol: HDL-C Ratio
Measured: Baseline and 12 months
Mean Change in Diastolic Blood Pressure
Measured: Baseline and 12 months

Secondary outcomes (2)

Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.
Measured: Baseline and 12 months
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.
Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Jun 2016

First posted21 Mar 2014 (estimated)
Study startApr 2014
Primary completionSep 2015
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02093702
Sponsor's protocol ID: AW-100-SD
Status last verified: Aug 2016
First submitted: 3 Mar 2014
Last updated: 6 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

J.R. Fowles, C. Shields, R.J.L. Murphy and P Dunbar. Developing Competency in Diabetes Education Volume 3: Physical Activity and Exercise Professional Resource Manual. The Canadian Diabetes Association. 2012. Toronto, Ontario. 110 pages.
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.
PubMed 24070961
Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F, Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J, Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007 Jan 2;115(1):114-26. doi: 10.1161/CIRCULATIONAHA.106.179294. Epub 2006 Dec 27.
PubMed 17192512
Gornall A, Levesque L, Sigal RJ. A Pilot Study of Physical Activity Education Delivery in Diabetes Education Centres in Ontario. Can J Diabetes. 2008;32(2):123-30. doi: 10.1016/S1499-2671(08)22009-5. Epub 2012 Dec 10.
PubMed 27056541
Canadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
Chudyk A, Petrella RJ. Effects of exercise on cardiovascular risk factors in type 2 diabetes: a meta-analysis. Diabetes Care. 2011 May;34(5):1228-37. doi: 10.2337/dc10-1881.
PubMed 21525503
Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.
PubMed 21540423
Plotnikoff RC, Taylor LM, Wilson PM, Courneya KS, Sigal RJ, Birkett N, Raine K, Svenson LW. Factors associated with physical activity in Canadian adults with diabetes. Med Sci Sports Exerc. 2006 Aug;38(8):1526-34. doi: 10.1249/01.mss.0000228937.86539.95.
PubMed 16888470
McManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
Majumdar SR, Johnson JA, Bowker SL, Booth GL, et al. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes. Can J Diabetes. 2005 2005;29:220-229.
McSweeney JC, Cody M, O'Sullivan P, Elberson K, Moser DK, Garvin BJ. Women's early warning symptoms of acute myocardial infarction. Circulation. 2003 Nov 25;108(21):2619-23. doi: 10.1161/01.CIR.0000097116.29625.7C. Epub 2003 Nov 3.
PubMed 14597589
Zanuso S, Jimenez A, Pugliese G, Corigliano G, Balducci S. Exercise for the management of type 2 diabetes: a review of the evidence. Acta Diabetol. 2010 Mar;47(1):15-22. doi: 10.1007/s00592-009-0126-3. Epub 2009 Jun 3.
PubMed 19495557
Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
PubMed 12421890
Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW. Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care. 2003 Mar;26(3):557-62. doi: 10.2337/diacare.26.3.557.
PubMed 12610001

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Structured Physical Activity Education Delivery on Hemoglobin A1c Levels, Blood Pressure, Lipid Profile, Body Mass Index, Waist Circumference, and Adherence to Canadian Diabetes Association Clinical Practice Guidelines Weekly Physical Activity Recommendations for Patients With Type 2 Diabetes Mellitus: A Pilot Study.
ClinicalTrials.gov ID: NCT02093702
Acronym / sponsor ID: AW-100-SD
Conditions: Type 2 Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Royal Victoria Hospital, CanadaUniversity, hospital or other
Study start: Apr 2014
Primary completion: Sep 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 21 Mar 2014 (estimated)
Results: Posted 6 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Unstructured Physical Activity and Exercise Education Delivery	Active comparator	Behavioral: Unstructured Physical Activity and Exercise Education50 subjects will receive the standard approach to physical activity and exercise education from a Certified Diabetes Educator.
Structured Physical Activity and Exercise Education Delivery	Experimental	Behavioral: Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach50 subjects will receive physical activity and exercise education and behaviour counseling from a qualified Exercise Specialist (Registered Kinesiologist). These subjects will receive access to a community health and fitness centre as well as exercise instruction and on-going support and motivation from a YMCA Wellness Coach who focuses on establishing healthy behaviors towards the attainment of personal goals. Subjects will be requested to complete a lifestyle questionnaire at each appointment with their Wellness Coach. Subjects will receive a Physical Activity and Exercise Journal that will help them keep track of their weekly physical activity and exercise activities.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Man or woman with type 2 diabetes
Ready to begin regular physical activity
Age equal to or greater than 18
Age equal to or less than 64.

Key exclusion criteria (7 listed)

Any vascular disease
Exhibits symptoms of coronary artery disease (CAD)
History of losing balance because of dizziness
History of losing consciousness
Has a bone or joint problem that could be made worse by a change in physical activity

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
Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach	Behavioural	Structured Physical Activity and Exercise Education Delivery
Unstructured Physical Activity and Exercise Education	Behavioural	Unstructured Physical Activity and Exercise Education Delivery

Primary outcome

Mean Change in Hemoglobin A1c (HbA1c) Levels
Time frame: Baseline and 12 months
Mean Change in Systolic Blood Pressure
Time frame: Baseline and 12 months
Mean Change in Waist Circumference
Time frame: Baseline and 12 months
Mean Change in Body Mass Index
Time frame: Baseline and 12 months
Mean Change in Serum Total Cholesterol
Time frame: Baseline and 12 months
Mean Change in HDL-C
Time frame: Baseline and 12 months
Mean Change in LDL-C
Time frame: Baseline and 12 months
Mean Change in Triglycerides (TGs)
Time frame: Baseline and 12 months
Mean Change in Total Cholesterol: HDL-C Ratio
Time frame: Baseline and 12 months
Mean Change in Diastolic Blood Pressure
Time frame: Baseline and 12 months

2 secondary outcomes

Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations
Time frame: Baseline and 12 months
Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations
Time frame: Baseline and 12 months

Results and safety

Results posted to the registry on 6 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard PA Education for People With T2DM (From a CDE)	2	2
Structured PA Education Program for People With T2DM	3	3

Primary outcome: Mean Change in Hemoglobin A1c (HbA1c) Levels

Time frame: Baseline and 12 months. Mean (Full Range). Unit: mmol/mol

Measure	Standard PA Education for People With T2DM (From a CDE) n = 2	Structured PA Education Program for People With T2DM n = 3
Value	0.001 (0.0007 to 0.0013)	-0.007 (-0.0073 to -0.0067)

Primary outcome: Mean Change in Systolic Blood Pressure

Time frame: Baseline and 12 months. Mean (Full Range). Unit: mm Hg

Measure	Standard PA Education for People With T2DM (From a CDE) n = 2	Structured PA Education Program for People With T2DM n = 3
Value	5.0 (2.0 to 7.0)	7 (3 to 10)

Primary outcome: Mean Change in Waist Circumference

Time frame: Baseline and 12 months. Mean (Full Range). Unit: cm

Measure	Standard PA Education for People With T2DM (From a CDE) n = 2	Structured PA Education Program for People With T2DM n = 3
Value	0.7 (-1.5 to 3.7)	-3.4 (-4.8 to -2.0)

Primary outcome: Mean Change in Body Mass Index

Time frame: Baseline and 12 months. Mean (Full Range). Unit: kg/m^2

Measure	Standard PA Education for People With T2DM (From a CDE) n = 2	Structured PA Education Program for People With T2DM n = 3
Value	0.6 (-1.2 to 1.8)	-2.0 (-2.8 to -1.0)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Structured PA Education Program for People With T2DM	0 of 0	0 of 0	Not reported
Standard PA Education for People With T2DM (From a CDE)	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundJ.R. Fowles, C. Shields, R.J.L. Murphy and P Dunbar. Developing Competency in Diabetes Education Volume 3: Physical Activity and Exercise Professional Resource Manual. The Canadian Diabetes Association. 2012. Toronto, Ontario. 110 pages.
Background: PubMed 24070961Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Booth G, Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Methods. Can J Diabetes. 2013 Apr;37 Suppl 1:S4-7. doi: 10.1016/j.jcjd.2013.01.010. Epub 2013 Mar 26. No abstract available.
Background: PubMed 17192512Buse JB, Ginsberg HN, Bakris GL, Clark NG, Costa F, Eckel R, Fonseca V, Gerstein HC, Grundy S, Nesto RW, Pignone MP, Plutzky J, Porte D, Redberg R, Stitzel KF, Stone NJ; American Heart Association; American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Circulation. 2007 Jan 2;115(1):114-26. doi: 10.1161/CIRCULATIONAHA.106.179294. Epub 2006 Dec 27.
Background: PubMed 27056541Gornall A, Levesque L, Sigal RJ. A Pilot Study of Physical Activity Education Delivery in Diabetes Education Centres in Ontario. Can J Diabetes. 2008;32(2):123-30. doi: 10.1016/S1499-2671(08)22009-5. Epub 2012 Dec 10.
BackgroundCanadian Institute for Health Information. Pan-Canadian Primary Health Care Indicator Update Report. Canadian Institute for Health Information, 2012. Ottawa, Ontario. 198 pages.
Background: PubMed 21525503Chudyk A, Petrella RJ. Effects of exercise on cardiovascular risk factors in type 2 diabetes: a meta-analysis. Diabetes Care. 2011 May;34(5):1228-37. doi: 10.2337/dc10-1881.
Background: PubMed 21540423Umpierre D, Ribeiro PA, Kramer CK, Leitao CB, Zucatti AT, Azevedo MJ, Gross JL, Ribeiro JP, Schaan BD. Physical activity advice only or structured exercise training and association with HbA1c levels in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2011 May 4;305(17):1790-9. doi: 10.1001/jama.2011.576.
Background: PubMed 16888470Plotnikoff RC, Taylor LM, Wilson PM, Courneya KS, Sigal RJ, Birkett N, Raine K, Svenson LW. Factors associated with physical activity in Canadian adults with diabetes. Med Sci Sports Exerc. 2006 Aug;38(8):1526-34. doi: 10.1249/01.mss.0000228937.86539.95.
BackgroundMcManus RM, Stitt LW, Bargh GJM. Population survey of diabetes knowledge and protective behaviours. Can J Diabetes. 2006;30:256-263.
BackgroundMajumdar SR, Johnson JA, Bowker SL, Booth GL, et al. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes. Can J Diabetes. 2005 2005;29:220-229.
Background: PubMed 14597589McSweeney JC, Cody M, O'Sullivan P, Elberson K, Moser DK, Garvin BJ. Women's early warning symptoms of acute myocardial infarction. Circulation. 2003 Nov 25;108(21):2619-23. doi: 10.1161/01.CIR.0000097116.29625.7C. Epub 2003 Nov 3.
Background: PubMed 19495557Zanuso S, Jimenez A, Pugliese G, Corigliano G, Balducci S. Exercise for the management of type 2 diabetes: a review of the evidence. Acta Diabetol. 2010 Mar;47(1):15-22. doi: 10.1007/s00592-009-0126-3. Epub 2009 Jun 3.
YMCA Wellness CoachingLink provided by the sponsor.
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.

Dr. Andrew Wozniak, MD, CCFP principal investigator

Barrie and Community Family Health Team

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 6 Oct 2016. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Hemoglobin A1c (HbA1c) Levels (time frame: Baseline and 12 months). The study lists 10 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 NCT02093702, which also lists 14 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 6 Oct 2016.