Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,
Graz, Austria
Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene
Innsbruck, Austria
Montreal Children's Hospital, McGill University Health Centre - Glen Site
Monrtreal, Quebec, Canada
Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls.
Time frame: baseline and 6 months
Change in peak oxygen uptake (%predicted)
Time frame: baseline to 6 months and baseline to 12 months
Change in maximal aerobic power (%predicted)
Time frame: baseline to 6 months and baseline to 12 months
Change in measured steps per day
Time frame: baseline to 6 months and baseline to 12 months
Change in exercise steps per day
Time frame: baseline to 6 months and baseline to 12 months
Change in reported physical activity
Time frame: baseline to 6 months and baseline to 12 months
Change in forced expiratory volume in 1 second (FEV1; %predicted)
Time frame: baseline to 6 months and baseline to 12 months
Change in forced vital capacity (FVC; % predicted)
Time frame: baseline to 6 months and baseline to 12 months
Change in residual volume in percent of total lung capacity (RV/TLC; %)
Time frame: baseline to 6 months and baseline to 12 months
Time to first exacerbation
Time frame: baseline to 6 months and baseline to 12 months
Number of upper respiratory tract infections
from diary
Time frame: baseline to 6 months and baseline to 12 months
Days on additional oral / intravenous antibiotics
from questionnaire
Time frame: baseline to 6 months and baseline to 12 months
Change in body mass index (kg/m2)
Time frame: baseline to 6 months and baseline to 12 months
Change in muscle mass (kg)
estimated from skinfold thickness
Time frame: baseline to 6 months and baseline to 12 months
Change in percent body fat
estimated from skinfold thickness
Time frame: baseline to 6 months and baseline to 12 months
Change in Quality of Life scales
from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)
Time frame: baseline to 6 months and baseline to 12 months
Change in depression, anxiety and stress scores
from Depression Anxiety Stress Scales
Time frame: baseline to 6 months and baseline to 12 months
Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load
standardized oral glucose tolerance test only patients without diabetes mellitus
Time frame: baseline to 9 months
Adverse events possibly or likely related to exercise
causality as judged by investigator
Time frame: baseline to 6 months and baseline to 12 months
Severe adverse events
Time frame: baseline to 6 months and baseline to 12 months
Serious adverse events
Time frame: baseline to 6 months and baseline to 12 months
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Hôpital Renée Sabran, Service : Maladies respiratoires
Hyères, France
Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq
Lille, France
Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques
Lille, France
Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires
Montpellier, France
Hôpital Necker, Service : Pneumologie et allergologie pédiatriques
Paris, France
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