The efficacy of the walk-bike on quality of life and exercise capacity in patients with idiopathic pulmonary fibrosis: a pilot study.

Background
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, progressive and
life-threatening disease of unknown cause. The prevalence of IPF in the
Netherlands is estimated to be 3200, with an incidence of 800-1600 a year.
There is a male predominance and most patients are between 50 and 80 years of
age. The median survival of IPF is 4 years.1 As the disease progresses,
worsening of lung function and gas exchange impairment cause hypoxemia during
physical activity leading to a downward spiral; 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.

Pharmacologic treatment options are limited. International studies showed that
use of a new drug in patient with IPF gives a small reduction in pulmonary
function decline. In these trials the effect on quality of life was not
evaluated and international debate exists about the clinical relevance of these
outcomes. In a selected, limited group of patients with IPF lung
transplantation can be an option. The mean waiting time for lung
transplantation in the Netherlands is 3 years and 33% of patients with IPF on
the waiting list die before they get the chance to have a lung transplant.

In this devastating progressive disease with limited treatment options,
treatments that could improve quality of life should be investigated more.
Non-pharmacologic treatment like pulmonary rehabilitation programs is
recommended by expert opinion for the majority of IPF patients to improve
quality of life and exercise tolerance. A review on physical training in
patients with different Interstitial Lung Disease including IPF indicates
pulmonary rehabilitation has a beneficial effect on quality of life and
functional exercise capacity in IPF patients. Often pulmonary rehabilitation
programs are offered in outpatient clinics and specialized rehabilitation
centers with a duration of 6 -12 weeks. Due to the limited life expectancy of
IPF patients and practical problems with decreased mobility and transport,
patients are often hesitant to participate in these external programs. Therefor
appropriate alternative programs should be considered for these patients. Also
the effect of these programs wanes when the program is discontinued.

A recent study demonstrated that a new-walking aid: the walk-bike or modern
draisine, improved exercise performance in Chronic Obstructive Pulmonary
Disease patients due to the more efficient way of moving without excessive
metabolic demand. The effectiveness of the walk-bike in subjects with IPF is
unknown. We hypothesize 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.

Primary objective
• To assess the effect of use of a walk-bike in IPF patients for 8 weeks on
health-related quality of life, measured with the St. George Respiratory
Questionnaire, at baseline, week 9 and week 18, in patients with IPF.

Secondary objectives
• To assess the change in measures of exercise capacity at 9 and 18 weeks
compared to baseline (6MWT, daily physical activities).
• To assess the change on health-related quality of life measured with the
questionnaires K-BILD and GAD-7 at week 9 and week 18 compared to baseline.

A randomized controlled crossover pilot study

The intervention is 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.

Patients with IPF participating in this study might have personal benefit from
participating in this study when using the walk-bike results in a better QoL.
The burden is low, patients will be asked to use the walk-bike every-day with a
minimum of one hour, register frequency and duration in a diary, to carry a
small pedometer for 7 days at baseline, 8 weeks, 9 and 18 weeks (group that
starts with intervention), or at baseline, 9, 17 and 18 weeks (group that
starts in the control group) and to fill in questionnaires at baseline, 9 and
18 weeks. The use of the walk-bike has not been associated with an increased
risk of falling or accidents in populations studied of the same age.
Use of the walk-bike is expected to change the quality of life and exercise
performance in a positive way, without side effects. Treatment decisions will
be at the discretion of the treating physician and not be influenced by the
study. The outcome of the study may improve future care of patients with IPF.