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Effects of an Exercise Program Among CF Patients With Dysglycemia (FKEX)

Primary Purpose

Cystic Fibrosis, Cystic Fibrosis Related Diabetes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
Institut de Recherches Cliniques de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring cystic fibrosis, exercise, Cystic fibrosis related diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CRIMontreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Exercise

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in glycemia at 2h of -1.5 mmol/L
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.

Secondary Outcome Measures

inflammatory marker change
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.
VO2max changes
Evaluate if regular combined physical activity program improves exercise tolerance in CF patient.
muscular strength
Evaluate if regular combined physical activity program improves muscle strength and endurance.
area under the insulin curve
Evaluate if regular combined physical activity program improves insulin sensitivity.
Changes in glycemia of -1.5mmol/L at 1h
Evaluate if regular combined physical activity program improves glucose tolerance at one hour of the OGTT.
quality of life changes
Evaluate if regular combined physical activity program improves quality of life in CF.
lean mass changes
Evaluate if regular combined physical activity program improves lean mass in CF.

Full Information

First Posted
April 18, 2014
Last Updated
July 29, 2015
Sponsor
Institut de Recherches Cliniques de Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT02127957
Brief Title
Effects of an Exercise Program Among CF Patients With Dysglycemia
Acronym
FKEX
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut de Recherches Cliniques de Montreal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of the investigators research program is to determine whether a combined exercise program (aerobic and resistance) improves abnormal glucose tolerance and diabetes control in CF patients. This program of exercises to increase strength and muscle endurance, exercise tolerance, will be assessed in a group of 12 CF patients with impaired glucose tolerance. The effect of exercise will be compared with a control group of 12 patients also glucose intolerant but do not participate in structured physical activity program. The duration of the exercise program will be 12 weeks and several measures (glucose tolerance, inflammatory profile, lung function, exercise capacity, muscle strength and endurance) will be conducted pre and post program to assess the program's impact .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Cystic Fibrosis Related Diabetes
Keywords
cystic fibrosis, exercise, Cystic fibrosis related diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Other
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in glycemia at 2h of -1.5 mmol/L
Description
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.
Time Frame
baseline and week 13
Secondary Outcome Measure Information:
Title
inflammatory marker change
Description
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.
Time Frame
baseline and week 13
Title
VO2max changes
Description
Evaluate if regular combined physical activity program improves exercise tolerance in CF patient.
Time Frame
baseline and week 13
Title
muscular strength
Description
Evaluate if regular combined physical activity program improves muscle strength and endurance.
Time Frame
baseline and week 13
Title
area under the insulin curve
Description
Evaluate if regular combined physical activity program improves insulin sensitivity.
Time Frame
basline and week 13
Title
Changes in glycemia of -1.5mmol/L at 1h
Description
Evaluate if regular combined physical activity program improves glucose tolerance at one hour of the OGTT.
Time Frame
basline and week 13
Title
quality of life changes
Description
Evaluate if regular combined physical activity program improves quality of life in CF.
Time Frame
baseline and week 13
Title
lean mass changes
Description
Evaluate if regular combined physical activity program improves lean mass in CF.
Time Frame
basline and week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Berthiaume, Md
Organizational Affiliation
Institut de Recherches Cliniques de Montreal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Remi Rabasa-Lhoret, Md
Organizational Affiliation
Institut de Recherches Cliniques de Montreal
Official's Role
Study Chair
Facility Information:
Facility Name
CRIMontreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27669451
Citation
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.
Results Reference
derived

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Effects of an Exercise Program Among CF Patients With Dysglycemia

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