Primary Objective: In 2 study groups, patients with COPD and patients with chronic heart failure:• To investigate whether, in comparison to unaided walking, the increase in 6 minute walking distance (6MWD) using a walking bike is greater than the…
ID
Source
Brief title
Condition
- Heart failures
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change (in meters) in 6 minute walking distance using a rollator versus a
walking bike
Secondary outcome
The changes in dyspnea (Borg), leg fatigue (Borg), heart rate, breathing
frequency, pulse, oxygen saturation, and inspiratory capacity (IC) during the
walking tests. Differences in levels of shame (Borg score) and satisfaction
(adjusted QUEST score) with rollator vs walking bike. Differences between
patients with COPD and chronic heart failure with respect to responses on
walking with rollator versus walking bike. Baseline characteristics will be
used to identify potential predictors of response.
Background summary
COPD as well as chronic heart failure is characterized by reduced exercise
capacity, which is associated with dyspnea and fatigue. Since patients with
COPD and patients with chronic heart failure experience such severe impairment,
wheeled walking aids might be beneficial.
In chronic heart failure the effect of walking aids has not been investigated
yet, whereas in COPD the use of a rollator consistently showed some improvement
in walking distance, dyspnea, and oxygen saturation, especially in the more
severely impaired patients. However rollator use in daily practice seems
somewhat limited, probably due to shame, so a more dynamic looking aid, such as
a walking bike, may be worthwhile to investigate.
The potential increase in exercise capacity using a walking bike as compared to
a rollator might be due to several reasons. The walking bike strongly reduces
weight-bearing by the lower extremities, which is supposed to improve walking
efficiency in patients with COPD as well as chronic heart failure. In addition,
arm-support might increase ventilatory capacity probably by improved function
of the accessory muscles that expand the rib cage. This beneficial effect is
assumed to be of greater importance in patients with COPD , whose diaphragms
are flattened and ineffective, because such patients depend more on the
inspiratory muscles of the rib cage as compared to patients with chronic heart
failure. In this perspective we hypothesize that both patients with COPD and
with chronic heart failure will benefit from walking with a walking bike, with
the most benefit being expected for the COPD patients.
Study objective
Primary Objective:
In 2 study groups, patients with COPD and patients with chronic heart failure:
• To investigate whether, in comparison to unaided walking, the increase in 6
minute walking distance (6MWD) using a walking bike is greater than the
increase in 6MWD due to walking with a rollator.
Secondary Objective(s):
In 2 study groups, patients with COPD and patients with chronic heart failure:
• To investigate whether, in comparison to unaided walking, the decrease in
dyspnea after walking a fixed distance (400 m test) using a walking bike is
greater than the decrease in dyspnea due to walking with a rollator.
• To investigate the effects of the use of a walking bike versus a rollator on
several additional physiologic and user friendliness variables: heart rate,
breathing frequency, pulse, oxygen saturation, inspiratory capacity, dyspnea,
fatigue, satisfaction with equipment and levels of shame during the 6-min walk
test and 400 meter test.
• To investigate whether there are differences between patients with COPD and
chronic heart failure with respect to responses on walking with rollator versus
walking bike
• To investigate whether predicting factors of beneficial effects of walking
with rollator or walking bike can be detected
Study design
This will be a randomized crossover intervention study
Intervention
All patients will perform 6MWT*s and 400m tests using a walking bike or
rollator in random order.
Study burden and risks
For this study there are no major risks involved. Most procedures are part of
the standard procedures at the outpatient clinics of our hospital.
The results of this study may be important for the group of patients with COPD
and chronic heart failure as it will show whether a walking bike is able to
improve exercise capacity in these disabled patients and might thereby be an
device that has potential to improve their quality of life. As such, we
consider the balance between risks and discomfort for the patient and the
possible benefit for these patient groups in the future acceptable.
H Dunantweg 2
8934AD Leeuwarden
NL
H Dunantweg 2
8934AD Leeuwarden
NL
Listed location countries
Age
Inclusion criteria
All patients:
45-80 yr, familiar with 6MWT;group 1COPD:
pulmonologist's diagnosis of COPD Gold II or III;group 2 chronic heart failure:
cardiologist's diagnosis of chronic heart failure NYHA 3 or 4
Exclusion criteria
All patients:
Disability limiting the ability to walk
Need for oxygen supplementation during exercise
Being used to walking with walking aid;group 1 COPD:
exacerbation COPD last 6 wks
history of congestive heart failure;group 2 chronic heart failure:
cardiac deterioration leading to hospital admission last 6 weeks
COPD
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 |
---|---|
CCMO | NL38594.099.11 |