| CTRI Number |
CTRI/2012/10/003034 [Registered on: 01/10/2012] Trial Registered Retrospectively |
| Last Modified On: |
01/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Walking ] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effectiveness of walking along with pedometer on glucose control and psychological profile in type 2 diabetics. |
|
Scientific Title of Study
|
Analysis of the effectiveness of physical activity protocols on physiological and psychological parameters of patients with type 2 diabetes. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U111-1121-9333 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shweta Shenoy |
| Designation |
Reader |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
09501114472 |
| Fax |
|
| Email |
shwet1999@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Shenoy |
| Designation |
Reader |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
09501114472 |
| Fax |
|
| Email |
shwet1999@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Shenoy |
| Designation |
Reader |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Faculty of sports medicine and physiotherapy, Guru Nanak Dev University Amritsar
Amritsar
PUNJAB
143005
India |
| Phone |
09501114472 |
| Fax |
|
| Email |
shwet1999@yahoo.com |
|
|
Source of Monetary or Material Support
|
| University Grant Commission
Dept of Sports Medicine and Physiotherapy GNDU Amritsar |
|
|
Primary Sponsor
|
| Name |
Department of Sports Medicine and Physiotherapy |
| Address |
Guru Nanak Dev University Amritsar |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Shenoy |
Guru Nanak Dev University Amritsar |
Faculty of sports medicine and physiotherapy GNDU amritsar
Amritsar
PUNJAB |
09501114472
shwet1999@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Department of Sports Medicine and Physiotherapy, Guru Nanak Dev University Amritsar, Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
continue with medication |
will not undergo any exercise |
| Intervention |
Walking along with Pedometer |
Supervised group(1)and Self Reported group(2)
Mode of training- walking
Duration of training - 16 week
frequency - 5 days/week
Group 1 - Each session will start with a 5 min warm up followed by 25-30 min of walking along with pedometer. this would follow by 5 minute cool down
Group 2- Subjects will go for walking with pedometer and report on daily basis.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Established cases of type 2 diabetes mellitus (at least
One year old)
2. Male or Female
3. Age group: 40 - 60 yrs
|
|
| ExclusionCriteria |
| Details |
1. Fluctuating blood pressure levels and blood glucose
Values above 250 mg/dl
2. Significant weight change
3. Significant renal disease
4. Restriction in physical activity due to disease,
Intermittent claudication, severe peripheral disease,Unstable cardiac and pulmonary disease, stroke, arthritis
5. Significant cognitive deficits
6. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fasting blood glucose, glycosylated hemoglobin, heart rate, blood pressure, doppler ultrasonography, BMI, Hip waist circumference, BMD, wellbeing, quality of life, Diabetes treatment satisfaction questionnaire |
Sept 2011- 0 week
Nov 2011 8 week
Jan 2011- 16 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized control trial to study the
effectiveness of physical activity protocols along with pedometer on
physiological and psychological parameters of patients with type 2 diabetes. Totally
105 type 2 diabetics would be recruited and will be divided in to one control
and two experimental groups with 35 subjects in each group. Experimental group
includes supervised exercise with pedometer and self reported exercise group
with pedometer. The
pedometer reading and the resting heart rate and blood pressure will be
recorded for all the sessions. The self reported group will continue with their
exercise protocol each day and record the number of steps walked and follow instructions
each day. After 8 week each subjects will report for follow up and repeat
readings of all parameters to document improvement in health status. They will
continue their protocols until 16th week where a final reading for
all subjects will be conducted. |