Effects of an Exercise Program Among CF Patients With Dysglycemia

Cystic Fibrosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127957
• Other study ID #: FKEX_12.356
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: July 29, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Cystic Fibrosis Related Diabetes
• Fibrosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	CRIMontreal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and week 13	No
Secondary	inflammatory marker change	Assess whether the practice of regular combined physical activity program modifies the inflammatory profile (C-reactive protein, cytokines (IL-1ß, IL-13, IL-6, IL-8, IL-10, TNF, CH3Li)) associated with CF diabetes.	baseline and week 13	No
Secondary	VO2max changes	Evaluate if regular combined physical activity program improves exercise tolerance in CF patient.	baseline and week 13	No
Secondary	muscular strength	Evaluate if regular combined physical activity program improves muscle strength and endurance.	baseline and week 13	No
Secondary	area under the insulin curve	Evaluate if regular combined physical activity program improves insulin sensitivity.	basline and week 13	No
Secondary	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.	basline and week 13	No
Secondary	quality of life changes	Evaluate if regular combined physical activity program improves quality of life in CF.	baseline and week 13	No
Secondary	lean mass changes	Evaluate if regular combined physical activity program improves lean mass in CF.	basline and week 13	No