Mucoviscidosis and Inflammation, Variability through Exercise and Training: physical exercise program

Mucoviscidosis and Inflammation, Variability through Exercise and Training: physical exercise program - MOVIT II

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35260

Enrollment

Registered

2008-02-12

Start date

2009-01-14

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis Mucoviscidosis

Interventions

CF patients only: The intervention used, will be a physical exercise program for 12 weeks (FITstrong) based on the physical fitness program of the Royal Canadian Air Force. This exercise program exi

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patiënten met CF: - CF patients diagnosed by clinical features and a positive sweat chloride test with a homozygote *F508 mutation - Sex: male and female - Age: 12 to 18 years old - Participants have to be clinically stable for at least 4 weeks, which means no use of extra oral or intravenous antibiotics for at least four weeks.;Healthy controls: - Age; 12 - 18 years old - Sex: male and female

Exclusion criteria

Exclusion criteria: Patients with cystic fibrosis and healthy controls: - Subjects with a physical exercise contraindication by a medical specialist - Subjects who use (inhalation) corticosteroids, and/ or immunosuppressive therapy - Subjects who have had a lung transplantation;Healthy controls: - Subjects who have allergies, asthma or auto-immune diseases.

Design outcomes

Primary

Measure	Time frame
Determinant: Physical exercise program based on the Canadian Air Force program with a duration of 12 weeks. Endpoint: Differences in the EIIR: difference between the EIIR before physical exercise training and the EIIR after physical exercise training. Different markers of the immune system will be collected from an i.v. access at two different time points.	—

Secondary

Measure	Time frame
Secondary endpoints: - Difference between basal immune values of patients with CF and healthy controls - Difference between basal immune values, pre-training versus post-training - Difference in pulmonary function - Difference in maximal exercise capacity - Difference in the exercise induced dyspnoea perception and muscle fatigue perception - Difference in quality of life - Difference in anthropometric values - Pulmonary exacerbation - Terminating the maximal exercise test prior to reaching voluntary exhaustion	—

Measure

Time frame

Secondary endpoints: - Difference between basal immune values of patients with CF and healthy controls - Difference between basal immune values, pre-training versus post-training - Difference in pulmonary function - Difference in maximal exercise capacity - Difference in the exercise induced dyspnoea perception and muscle fatigue perception - Difference in quality of life - Difference in anthropometric values - Pulmonary exacerbation - Terminating the maximal exercise test prior to reaching voluntary exhaustion

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)