The main objective of this study is to assess more thoroughly the differences in gait patterns between COPD patients and healthy controls. Other objectives are to assess differences in gait patterns between GOLD stages and two age groups in healthy…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 6MWD
- variability of Centre of Mass in medio-lateral direction
Secondary outcome
- Variability of Centre of Mass (COM) in anterior-posterior (COMAP) and
vertical (COMV) direction
- Centre of Pressure (COP) in medio-lateral, anterior-posterior and vertical
direction, respectively COPML, COPAP, COPV
- Average walking speed
- Step length
- Stride length
- Cadence
- Number of stops (assessed by D-flow software)
- Lower-limb muscle strength and endurance (Biodex, Biodex Medical Systems
Inc., New York, US)
- Transcutaneous oxygen saturation during each 6MWT in hallway and on treadmill
using a handheld pulse oximeter.
- Borg scores of all 6MWT
- Lung function using post-bronchospirometry
- Resting ECG, evaluated by the physician
- Body composition using DEXA
- Balance using the TUG-test
- 6MWD in hallway
- While performing the 6MWT in the hallway and on the treadmill, the Minimod
accelerometer (McRoberts, the Hague, the Netherlands; size 8.5x5.0x1.0 cm;
weight 70 g) will be attached to the trunk at the height of the sacrum using an
elastic belt. Matlab software (MathWorks, Eindhoven, the Netherlands) will be
used to calculate step time, step length, acceleration intensity, cadence and
acceleration amplitude variability.
Background summary
Patients with COPD suffer from dyspnea, which is an important cause of
deterioration of functional health. Dyspnea can cause physical inactivity and
worsening of the disease. Most COPD patients have therefore a limited
performance in functional activities e.g. walking. Besides, previous research
has pointed out that COPD patients are less active and have a different gait
pattern compared to healthy persons. This directs to balance disturbances in
COPD patients.
This study will be used to characterize the differences in gait patterns
between COPD patients and healthy controls. Hence results can give insight in
gait patterns, performance, kinetics and kinematics during walking, which can
lead to improvement of evulations of activity programs and measurements of
improvements in health status of COPD patients.
The hypothesis of this study is:
1. Gait patterns in COPD patients differ from healthy subjects.
Study objective
The main objective of this study is to assess more thoroughly the differences
in gait patterns between COPD patients and healthy controls. Other objectives
are to assess differences in gait patterns between GOLD stages and two age
groups in healthy persons. Finally, to assess difference in gait pattern before
and after pulmonary rehabilitation, while differentiating the location of
rehabilitation (in CIRO+ or CIRO+ rehabilitation network) .
Study design
This study is a cross sectional and observational study.
Study burden and risks
Regular pulmonary rehabilitation, baseline and outcome assessments will not be
interfered in COPD patients at CRIO+ or rehabilitation network. COPD patiënts
have to perform four 6MWT on the treadmill and one practice session.
Healthy controls perform 2 6MWT on the treadmill and one practice session.
Furthermore, healthy controls undergo measurements, which are comparable to
those of the assessments for COPD patients: 1 6MWT in hallway, lower limb
muscle strength and endurance, body composition, resting ECG, lung function and
balance test. These measurements are incorporated into the regular
rehabilitation program at CIRO+, therefore, healthy controls are not exposed to
high risks.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
1. Aged 40-85 years (COPD patiënts en controls age group 1) and aged 20-39 (controls age group 2).
2. Diagnosis of COPD according to GOLD guidelines (stage I-IV), only applicable for COPD patients.
3. Referral for assessment in CIRO+, and pulmonary rehabilitation in CIRO+ or CIRO+ rehabilitation network.
4. Subject is able to walk without walking aids.
5. Clinically stable evaluated by the physician.
Exclusion criteria
1. Neuromuscular co-morbidities
2. Subject is unable to walk without walking aids
3. Subject with open wounds
4. Medical history of asthma, lung cancer, sarcoidosis, tubercolosis, long fibrosis, or any other significant respiratory disease; having undergone lung surgery (e.g. lung volume reduction, lung transplantation); any clinical relevant disease which in the opinion of the investigator may influence the results of the study.
5. Other significant respiratory disease or chronic heart failure in controls.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46880.060.13 |
| Other | Onderzoek wordt geregistreerd zodra goedkeuring is ontvangen (op www.trialregister.nl) |
| OMON | NL-OMON22446 |