Effects of an Exercise Program Among CF Patients With Dysglycemia
NCT ID: NCT02127957
Last Updated: 2015-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2013-07-31
2015-07-31
Brief Summary
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Detailed Description
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All participants who agree to participate in the research project must undergo a short telephone interview (20 minutes) and 4 assessment visits ( approximately 1-5 hours) Pre (2 visits ) and post (2 visits ) study . The control patients with delayed exercises conduct a further assessment visit at the end of the training.
GROUP 1 EXERCISES : Patients in exercises group will be required to take part of two supervised training sessions and 8 follow up phone call . The exercise program will be performed three times per week for about one hour .
GROUP 2 CONTROL: Participants in the control group will be contacted by phone once a month following entry into the study. On this occasion a reminder to complete the physical activity log will be realized. Following the visit #6 , patients in the control group will be invited to participate in a second study phase to participate in supervised exercise program . This participation will involve an additional 12 weeks of follow-up, which included the same visit as Group 1 with exercises. In this case, to simplify participation and reduce the volume of blood collected , the final visit (#5) of the project will also be the first visit of exercises phase. This part of study, involves 2 supervised training sessions and 8 follow up phone call . The exercises program will be performed three times per week for about one hour .
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Exercise
Exercise group will have 6 visit and 8 phone call. Subject will have to do prescribed exercice for 1h, 3 times a week for 12 weeks.
Exercise
Exercise will be prescribed by kinesiologist and will be done 3 times a week for 1 hour by subject. Every 4 weeks subject will be on supervised training session.
Control
Control group will have 4 visit and 3 phone call. They will receive standard counselling for exercise in cystic fibrosis, but no prescribed exercice will be given.
No interventions assigned to this group
Interventions
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Exercise
Exercise will be prescribed by kinesiologist and will be done 3 times a week for 1 hour by subject. Every 4 weeks subject will be on supervised training session.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of CF documented.
* Obstructive ventilatory deficit light to moderate , as defined in the guidelines of the ATS / ERS , an FEV / FVC ratio \> 70% and ≥ 40% FEV .
* Stable health status, no episode of superinfection in the past 6 weeks.
* Impaired glucose tolerance , glucose \> 11.1 mmol / L at the 1st hour of the OGTT or unmedicated CFRD.
* Patients who wants to participate in an exercise program for 12 weeks.
* Sedentary (less than 105 min / week of physical activity ) .
Exclusion Criteria
* Exacerbation with intravenous antibiotics .
* Severe obstructive deficit as defined by FEV \<40% , with an FEV / FVC ratio \<70 %.
* Any other disease or condition that may limit exercise performance .
* Without treatment with oral hypoglycemia , insulin, oral anti -inflammatory and other treatments that may influence glucose metabolism (patient under cortef accepted) .
* Hemoptysis ( \> 50-60 cc) in the last 6 weeks.
* Desaturation during exercise.
18 Years
ALL
No
Sponsors
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Institut de Recherches Cliniques de Montreal
OTHER
Responsible Party
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Yves Berthiaume
Dr Yves Berthiaume,
Principal Investigators
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Yves Berthiaume, Md
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherches Cliniques de Montreal
Remi Rabasa-Lhoret, Md
Role: STUDY_CHAIR
Institut de Recherches Cliniques de Montreal
Locations
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CRIMontreal
Montreal, Quebec, Canada
Countries
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References
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Beaudoin N, Bouvet GF, Coriati A, Rabasa-Lhoret R, Berthiaume Y. Combined Exercise Training Improves Glycemic Control in Adult with Cystic Fibrosis. Med Sci Sports Exerc. 2017 Feb;49(2):231-237. doi: 10.1249/MSS.0000000000001104.
Other Identifiers
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FKEX_12.356
Identifier Type: -
Identifier Source: org_study_id