Analysis of the effectiveness of physical activity protocols on physiological and psychological parameters of patients with type 2 diabetes.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Fasting blood glucose, glycosylated hemoglobin, heart rate, blood pressure, doppler ultrasonography, BMI, Hip waist circumference, BMD, wellbeing, quality of life, Diabetes treatment satisfaction questionnaire
Study Overview
Brief Summary
This study is a randomized control trial to study theeffectiveness of physical activity protocols along with pedometer onphysiological and psychological parameters of patients with type 2 diabetes. Totally105 type 2 diabetics would be recruited and will be divided in to one controland two experimental groups with 35 subjects in each group. Experimental groupincludes supervised exercise with pedometer and self reported exercise groupwith pedometer. Thepedometer reading and the resting heart rate and blood pressure will berecorded for all the sessions. The self reported group will continue with theirexercise protocol each day and record the number of steps walked and follow instructionseach day. After 8 week each subjects will report for follow up and repeatreadings of all parameters to document improvement in health status. They willcontinue their protocols until 16th week where a final reading forall subjects will be conducted.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Established cases of type 2 diabetes mellitus (at least One year old)
- •Male or Female
- •Age group: 40.
Exclusion Criteria
- •Fluctuating blood pressure levels and blood glucose Values above 250 mg/dl
- •Significant weight change
- •Significant renal disease
- •Restriction in physical activity due to disease, Intermittent claudication, severe peripheral disease,Unstable cardiac and pulmonary disease, stroke, arthritis
- •Significant cognitive deficits 6.
Outcomes
Primary Outcomes
Fasting blood glucose, glycosylated hemoglobin, heart rate, blood pressure, doppler ultrasonography, BMI, Hip waist circumference, BMD, wellbeing, quality of life, Diabetes treatment satisfaction questionnaire
Time Frame: Sept 2011- 0 week | Nov 2011 8 week | Jan 2011- 16 week
Secondary Outcomes
No secondary outcomes reported