Effects of an Exercise Program Among CF Patients With Dysglycemia

NCT02127957 | Completed

• 1 other identifier: FKEX_12.356
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 .

Conditions

Cystic Fibrosis; Cystic Fibrosis Related Diabetes

Keywords

cystic fibrosis; exercise; Cystic fibrosis related diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• inflammatory marker change

  baseline and week 13

• VO2max changes

  baseline and week 13

• muscular strength

  baseline and week 13

• area under the insulin curve

  basline and week 13

• Changes in glycemia of -1.5mmol/L at 1h

  basline and week 13

Study Arms (2)

Exercise

OTHER

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.

Other: Exercise

Control

NO INTERVENTION

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.

Interventions

Exercise OTHER

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.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

CRIMontreal

Montreal, Quebec, H2W 1R7, Canada

Location

Related Publications (1)

• 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.

  PMID: 27669451 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Yves Berthiaume, Md

  Institut de Recherches Cliniques de Montreal

  PRINCIPAL INVESTIGATOR

• Remi Rabasa-Lhoret, Md

  Institut de Recherches Cliniques de Montreal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Yves Berthiaume,

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: May 1, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CA (1)