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ID
Source
Brief title
Health condition
Idiopathic pulmonary fibrosis (IPF), walk-bike, quality of life, exercise capacity
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in total score in health-related quality of life questionnaire SGRQ
Secondary outcome
-Change in exercise capacity measures
(distance (m) during 6-minute-walk-test and average steps per day)
-Change in scores in health-related quality of life questionnaires K-BILD and GAD-7
-Change in component scores (symptoms, activity and impact) in health-related quality of life measured with SGRQ.
Background summary
IPF is a devastating progressive disease with limited treatment options. Dyspnea and fatigue lead to a reduction of daily physical activities, exercise tolerance, muscle strength and quality of life. Problems reported by IPF patients are social isolation, increased level of dependency and immobility.We hypothesized that use of this walk-bike in daily life extends the range and everyday mobility of IPF patients, thereby decreases the level of dependency and social isolation, factors that are associated with quality of life. If, with this low-cost intervention, daily activities of IPF patients increase, exercise capacity might improve too. The objective of this pilot study is to assess the efficacy of the ¡°walk-bike¡± on quality of life and exercise capacity in IPF patients. In this crossover pilot study participants will be randomly allocated to either an 8 weeks-exercise intervention (using a walk-bike) or receive standard treatment only. After the follow-up visit at week 9 patient will cross-over to the other group.
Study objective
Use of this walk-bike in daily life extends the range and everyday mobility of IPF patients, thereby decreases the level of dependency and social isolation, factors that are associated with quality of life. If, with this low-cost intervention, daily activities of IPF patients increase, exercise capacity might improve too.
Study design
There are three study visits:
-Baseline measurements before randomly allocation to either intervention group (use of walk-bike) or control group.
-Post measurements at week 9
-Crossover to other group.
-Post measurements at week 18.
Intervention
Use of a walk-bike in daily life during 8 weeks, with a minimum of 1 hour per day. The patient will be asked to record the time using the walk-bike in a diary. At baseline instructions will be given and a training under supervision.
The control group will receive standard treatment only.
Inclusion criteria
-IPF patients
-Diagnosis of IPF, including probable and possible diagnosis according to ATS/ERS criteria
-Written informed consent
-TLCOc ¡Ý 30%(pred) and FVC ¡Ý 50% (pred)
-6MWD ¡Ý 150 m
-Being clinically stable
-Absolute decline in TLCOc and FVC should be less than 10% in the past 6 months.
Exclusion criteria
-Participation in a formal rehabilitation program within 4 months of start of study
-Musculoskeletal disorders
-Severe cardiac diseases (ejection fraction < 30%, daily angina, or otherwise specified by treating cardiologist)
-Unable to understand informed consent
-Other conditions that hamper the use of a walk-bike
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5186 |
| NTR-old | NTR5334 |
| Other | NL45411.078.14 : MEC- 2014-047 Erasmus MC |