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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2018/03/012771
Date of registration: 22-03-2018
Prospective Registration: No
Primary sponsor: Dr G Arun Maiya
Public title: How will Physical Activity Program improve blood sugar?
Scientific title: Physical activity program on glucose level in pre-diabetes- A pre-post design
Date of first enrolment: 15-04-2015
Target sample size: 80
Recruitment status: Closed to Recruitment of Participants
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11523
Study type:  Observational
Study design:  Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
 
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr G Arun Maiya   
Address:  School of Allied Health Sciences, Manipal University, Manipal, Udupi 576104 Udupi, KARNATAKA India
Telephone: 09845350823
Email: ajmaiya@gmail.com
Affiliation:  School of Allied Health Sciences
Name: Mr Abraham Samuel Babu   
Address:  School of Allied Health Sciences, Manipal University, Manipal, Udupi 576104 Udupi, KARNATAKA India
Telephone: 09845350823
Email: ajmaiya@gmail.com
Affiliation:  School of Allied Health Sciences
Key inclusion & exclusion criteria
Inclusion criteria: 1. individuals with pre-diabetes (The criteria for diagnosis being value of fasting plasma glucose level from 6.1 mmol/l (110 mg/dL) to 6.9 mmol/L (125 mg/dL) by WHO and fasting plasma glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125 mg/dL) by ADA)

2.individuals fulfilling the criteria for sedentary, low and moderate PA

3.BMI higher than 25 (overweight)


Exclusion criteria: progressive worsening of exercise tolerance and dyspnea at rest or on exertion

- patients with known cardiopulmonary problems

- recent embolism

- thrombophlebitis

- myocardial infarction within previous 3 weeks

- new onset atrial fibrillation

-resting heart rate more than 120bpm

-hypothyroidism, parathyroidism

- other musculoskeltal or neurological disorder which are contra indicated in exercise training


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Intervention(s)
Intervention1: PHYSICAL ACTIVITY: physical activity promotion in the routine of the individual will be increased as per the individual choice.
Intervention2: physical activity: physical activity will be promoted in individual routine as per individual choice and a telephonic interview will be taken after 4 weeks and will be followed up for 8 weeks
Control Intervention1: nil: nil
Primary Outcome(s)
glucose levelTimepoint: baseline, 8th week
Secondary Outcome(s)
physical activity in MET min/weekTimepoint: baseline, 4th week and 8th week
Secondary ID(s)
NIL
Source(s) of Monetary Support
Kasturba Hospital and Deaprtment of Physiotherapy,School Of Allied Health Sciences
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 11/03/2015
Contact:
Institutional Ethics Committee, Kasturba Hospital, Manipal
Results
Results available:
Date Posted:
Date Completed: 10/02/2016
URL:
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