Effects of an Individualized Exercise Program on Health-related and Skill/Performance-related fitness in CF.

NCT03518697 | Completed

• 1 other identifier: 14-6117-BO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to evaluate the effects of a partially supervised exercise program on different aspects of physical fitness, despite VO2peak, lung function, quality of life and sleep quality in children, adolescents and adults with Cystic Fibrosis.

Conditions

Cystic Fibrosis

Keywords

Exercise; Physical fitness; Physical activity; Accelerometer; Sleep

Outcome Measures

Primary Outcomes (1)

• Change of habitual physical activity in hours/day

  Measurement of the time of physical activity in hours/day by accelerometry (ActiGraph GT3X, Penascola, USA)

  at baseline, after 6 and 12 month

Secondary Outcomes (26)

• Change of the quality of life in Cystic Fibrosis

  at baseline, after 6 and 12 month

• Change of the duration of sleep in hours

  at baseline, after 6 and 12 month

• Change of the quality of sleep in percent

  at baseline, after 6 and 12 month

• Determination of the exercise related barriers and barrier management in physical exercise

  at baseline

• Change of habitual physical activity in steps/day

  at baseline, after 6 and 12 month

Study Arms (2)

Exercise Group

EXPERIMENTAL

1. First 6 months supervised exercise program with telephone contact every two weeks 2. Second 6 months exercise program without telephone contact 3. Patients should increase habitual daily physical activity for 10-20 minutes per day 5 times per week 4. Activities were chosen according to the preferences, interests, and severity of disease of the patients 5. Activites should improve endurance, strength, coordination and flexibility 6. Every three month regular vistit at the CF care center (medical examination, lung function, exercise testing, counselling and evaluation of activities by acceleometry and if appropirate adaption of exercise program)

Behavioral: exercise program

Control-Group

NO INTERVENTION

1. 12 months usual routine care and habitual exercise in daily life. 2. At start and after 12 month assessment of habitual exercise with accelerometry (Actigraph GTX3)

Interventions

exercise program BEHAVIORAL

The exercise program is planned as a "low-threshold exercise program "with low barriers to participate. Patients will be asked about their interests and preferences of sports activities to conceive the exercise program together with the patients.

Exercise Group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of CF
• Informed consent

You may not qualify if:

• Cardiac arrhythmias with exercise
• Patients with cor pulmonale
• Colonization with Burkholderia cenocepacia, Methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Gram-negative (MRGN) pathogens (3 and 4 MRGN)
• Patients with untreated diabetes

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (3)

St. Josef-Hospital im Katholischen Klinikum Bochum, Klinik für Kinder und Jugendmedizin, Alexandrinenstrasse 5

Bochum, 44791, Germany

Location

Universitätsklinikum Essen, Klinik für Kinderheilkunde III, Pädiatrische Pneumologie und Schlafmedizin, Hufelandstr. 55

Essen, 45147, Germany

Location

Ruhrlandklinik Essen, Westdeutsches Lungenzentrum am Universitätsklinikum Essen, Tuschener Weg 40

Essen, 45239, Germany

Location

Related Publications (1)

• Dietz-Terjung S, Gruber W, Sutharsan S, Taube C, Olivier M, Mellies U, Koerner-Rettberg C, Dillenhofer S, Stehling F, Welsner M. Association between habitual physical activity (HPA) and sleep quality in patients with cystic fibrosis. Sleep Breath. 2021 Jun;25(2):609-615. doi: 10.1007/s11325-020-02130-0. Epub 2020 Jul 14.

  PMID: 32661789 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Resistance Training

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)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Florian Stehling, Head of Pediatric Pulmonology, Children´s Hospital

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 8, 2018
• Study Start: September 10, 2014
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)