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Effects of a 6-months Partially Supervised Conditioning Program in CF (ACTIVATE-CF)

This study is not yet open for participant recruitment.
Verified December 2012 by Wuerzburg University Hospital
Sponsor:
Information provided by (Responsible Party):
Prof. Helge Hebestreit, Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01744561
First received: December 5, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 6-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 this intervention after 6 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.


Condition Intervention Phase
Cystic Fibrosis
 Behavioral: Exercise Intervention
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of a 6-months Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in peak oxygen uptake (%predicted) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in maximal aerobic power (%predicted) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in measured steps per day [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in exercise steps per day [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in reported physical activity [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in forced expiratory volume in 1 second (FEV1; %predicted) [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • Change in forced vital capacity (FVC; % predicted) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Change in residual volume in percent of total lung capacity (RV/TLC; %) [ Time Frame: baseline, 3 and 6 months ] [ Designated as safety issue: No ]
  • Time to first exacerbation [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
  • Number of upper respiratory tract infections [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    from diary

  • Days on additional oral / intravenous antibiotics [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    from questionnaire

  • Change in body mass index (kg/m2) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in muscle mass (kg) [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    estimated from skinfold thickness

  • Change in percent body fat [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    estimated from skinfold thickness

  • Change in Quality of Life scales [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)

  • Change in depression, anxiety and stress scores [ Time Frame: baseline to 6 months and baseline to 12 months ] [ Designated as safety issue: No ]
    from Depression Anxiety Stress Scales

  • Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load [ Time Frame: baseline and 6 months; 6 months and 12 months ] [ Designated as safety issue: No ]
    standardized oral glucose tolerance test only patients without diabetes mellitus

  • Adverse events possibly or likely related to exercise [ Time Frame: baseline to 6 and to 12 months ] [ Designated as safety issue: Yes ]
    causality as judged by investigator

  • Severe adverse events [ Time Frame: baseline to 6 and to 12 months ] [ Designated as safety issue: Yes ]
  • Serious adverse events [ Time Frame: baseline to 6 and to 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Compliance with the exercise goal [ Time Frame: baseline to 6 and 12 months ] [ Designated as safety issue: No ]
    based on questionnaire and diary


Estimated Enrollment: 292
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Intervention
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.
 Behavioral: Exercise Intervention
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.
No Intervention: Control
Keep activity level constant

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Cystic Fibrosis
  • Age ≥12 years
  • Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted
  • Access to the internet

Exclusion Criteria:

  • Participation in another clinical trial up to 4 weeks prior to the first baseline visit
  • Pregnancy/Breastfeeding
  • Inability to exercise
  • More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months.
  • Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
  • Cardiac arrhythmias with exercise
  • Requiring additional oxygen with exercise
  • Recent diagnosis of diabetes 3 months prior to screening or at screening
  • Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline)
  • At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744561

Contacts
Contact: Helge U Hebestreit, Prof. Dr. +49 931 201 27728 hebestreit@uni-wuerzburg.de

Locations
Germany
Children´s Hospital of the University
Würzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
  More Information

Additional Information:
web-based diary and information - under construction  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Prof. Helge Hebestreit, Professor Dr. med., Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT01744561     History of Changes
Other Study ID Numbers: ACT-CF-001
Study First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Wuerzburg University Hospital:
Exercise
Motivation
Feedback
web-based diary
pedometer

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013