- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127957
Effects of an Exercise Program Among CF Patients With Dysglycemia (FKEX)
Effects of a Program of Aerobic and Resistance Exercises Combined in Patients With Cystic Fibrosis (CF) With Impaired Glucose Tolerance or Diabetes Related to CF Without Medication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 24 subjects with CF with impaired glucose tolerance or with diabetes related to CF (CFRD) unmedicated will be recruited. Participants will be recruited through a research nurse in CF , which will analyze the available data to medical records and seek the participation of subjects who meet the inclusion and exclusion criteria . Patients receive during their visit to the outpatient clinic of FK at Hotel -Dieu du CHUM hospital , a inform consent form (ICF) for the study. Their intention to participate and the main inclusion and exclusion criteria will be confirmed in a telephone interview conducted by a member of the team at the IRCM. Finally, during the visit at the IRCM , the subject will get answer to his question for ICF and ICF will be signed before any procedure.
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Quebec
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Montréal, Quebec, Canada, H2W 1R7
- CRIMontreal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- Men or women 18 years and older.
- 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 of respiratory symptoms with or without hospitalization , or use of oral antibiotics in the last 6 weeks.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glycemia at 2h of -1.5 mmol/L
Time Frame: baseline and week 13
|
Evaluate if patient with CF have improved glucose tolerance at the second hour of a Oral glucose tolerance test (OGTT) following a combined exercise program.
|
baseline and week 13
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inflammatory marker change
Time Frame: baseline and week 13
|
Assess whether the practice of regular combined physical activity program modifies the inflammatory profile (C-reactive protein, cytokines (IL-1β, IL-13, IL-6, IL-8, IL-10, TNF, CH3Li)) associated with CF diabetes.
|
baseline and week 13
|
VO2max changes
Time Frame: baseline and week 13
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Evaluate if regular combined physical activity program improves exercise tolerance in CF patient.
|
baseline and week 13
|
muscular strength
Time Frame: baseline and week 13
|
Evaluate if regular combined physical activity program improves muscle strength and endurance.
|
baseline and week 13
|
area under the insulin curve
Time Frame: basline and week 13
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Evaluate if regular combined physical activity program improves insulin sensitivity.
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basline and week 13
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Changes in glycemia of -1.5mmol/L at 1h
Time Frame: basline and week 13
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Evaluate if regular combined physical activity program improves glucose tolerance at one hour of the OGTT.
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basline and week 13
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quality of life changes
Time Frame: baseline and week 13
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Evaluate if regular combined physical activity program improves quality of life in CF.
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baseline and week 13
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lean mass changes
Time Frame: basline and week 13
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Evaluate if regular combined physical activity program improves lean mass in CF.
|
basline and week 13
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yves Berthiaume, Md, Institut de recherches cliniques de Montreal
- Study Chair: Remi Rabasa-Lhoret, Md, Institut de recherches cliniques de Montreal
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FKEX_12.356
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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