The primary objective is to determine if patients with chronic obstructive pulmonary disease (COPD) have an altered adaptation potential of the reactive stepping response following repeated mechanical perturbations while walking.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the reactive adaptation potential measured during
the locomotor plasticity assessment protocol with the Gait Real-time Analysis
Interactive Lab. This will be calculated as the magnitude of change in the
margin of stability at touchdown of the first step after the perturbation
before and after repetition of the perturbation.
Secondary outcome
Walking speed, step width, step length, cadence at touchdown of the first and
following recovery steps after each perturbation.
Background summary
Patients with chronic obstructive pulmonary disease (COPD) show balance
disturbances in contrast to healthy peers. In addition, patients with COPD have
an increased risk for falls. Falls usually ocuur during walking and are often
attributed to age-related neuromuscular deficiences, for example reduced muscle
strength. The ability to react and take a large, balance recovery step
following perturbations (e.g. trip, slip or stumble) is an important factor in
recovering from mechanical perturbations. However, recovery stepping responses
are diminished in older subjects and might be affected even more in patients
with COPD due to systemic effects of the disease. Consequently, a pilot study
will be conducted to gain insight in the consequences of COPD on the adaptation
potential and initial recovery response to mechanical perturbation.
Study objective
The primary objective is to determine if patients with chronic obstructive
pulmonary disease (COPD) have an altered adaptation potential of the reactive
stepping response following repeated mechanical perturbations while walking.
Study design
This study is an observational pilot study
Study burden and risks
Participation in the pilot study will require one visit to Ciro (flexible
depending on availability of subjects) with a time commitment including all
measurements of between 1.5 and 2 hours.
All subjects will undergo measurements of their height and weight.
The first familiarisation session on the treadmill will take maximal 9 minutes.
After a period of rest, the second familiarisation session will take maximal 13
minutes.
After a period of rest, the gait perturbation protocol will take about 15
minutes.
The treadmill sessions could be fatiguing and subjects need to familiarize with
treadmill walking. A subject's balance could be disturbed during the gait
perturbation protocol. However, additional safety measures are taken: a subject
will wear a safety harness, the system has one emergency switch in case
subjects tend to walk past the treadmill safety zone, there is a manual safety
switch to terminate the treadmill trial, there is CPR emergency button in the
room in which the data are collected, subjects will conduct two treadmill
familiarisation sessions prior to the gait perturbation protocol in order to
accustom to the treadmill. Finally, the researcher, a certified GRAIL operator,
will direct the subject during the measurements.
Hornerheide 1
Horn 6085 NM
NL
Hornerheide 1
Horn 6085 NM
NL
Listed location countries
Age
Inclusion criteria
Older healthy adults:
- Healthy subjects
- Aged between 50-80 years old
- No known musculoskeletal disease, condition or injury that could negatively affect walking or balance ability
- No history of balance problems, dizziness or walking difficulties
- Must be able to walk at comfortable speed for 30 minutes without stopping
- Informed consent given;Patients with COPD
- Main diagnosis is COPD, diagnosed at CIRO (FEV1/FVC <0.70)
- Aged between 50-80 years old
- Must be able to perform the 6-minute walk test without a stop and without the use of walking aids
- Must be stable: no exacerbation of COPD, defined as an acute event characterized by a worsening of the patient*s respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication, within 4 weeks to data collection
- No chronic oxygen use
- Informed consent given
Exclusion criteria
- musculoskeletal disease, condition or injury
- subject is unable to walk without walking aids
- subject is unable to perform the 6-minute walk test without a stop
- subject with open wounds
- subject with balance problems, dizziness or walking difficulties (for healthy older adults)
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 | NL61317.100.17 |
| Other | Onderzoek wordt geregistreerd zodra goedkeuring is ontvangen (op www.trialregister.nl) |