Main
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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:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2018/03/012771 |
Date of registration:
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22-03-2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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How will Physical Activity Program improve blood sugar?
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Scientific title:
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Physical activity program on glucose level in pre-diabetes- A pre-post design |
Date of first enrolment:
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15-04-2015 |
Target sample size:
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80 |
Recruitment status: |
Closed to Recruitment of Participants |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11523 |
Study type:
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Observational |
Study design:
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Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr G Arun Maiya
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Address:
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School of Allied Health Sciences, Manipal University, Manipal, Udupi
576104
Udupi, KARNATAKA
India |
Telephone:
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09845350823 |
Email:
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ajmaiya@gmail.com |
Affiliation:
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School of Allied Health Sciences |
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Name:
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Mr Abraham Samuel Babu
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Address:
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School of Allied Health Sciences, Manipal University, Manipal, Udupi
576104
Udupi, KARNATAKA
India |
Telephone:
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09845350823 |
Email:
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ajmaiya@gmail.com |
Affiliation:
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School of Allied Health Sciences |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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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
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Primary Outcome(s)
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glucose levelTimepoint: baseline, 8th week
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Secondary Outcome(s)
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physical activity in MET min/weekTimepoint: baseline, 4th week and 8th week
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Source(s) of Monetary Support
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Kasturba Hospital and Deaprtment of Physiotherapy,School Of Allied Health Sciences
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Ethics review
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Status: Approved
Approval date: 11/03/2015
Contact:
Institutional Ethics Committee, Kasturba Hospital, Manipal
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Results
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Results available:
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Date Posted:
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Date Completed:
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10/02/2016 |
URL:
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