Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NA
Study information
Scientific title
Nordic walking to improve functional exercise capacity and daily physical activities in chronic obstructive pulmonary disease (COPD): a randomised controlled trial
Acronym
Study hypothesis
The aim of the present study was to determine whether and to what extent Nordic walking is feasible in increasing functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Additionally, we aimed to determine short- and long-term effects of Nordic walking on daily physical activity level, exercise performance and mood status in patients with COPD.
Ethics approval
Ethics Committee of Vienna (Ethikkommission der Stadt Wien), approved on 15/03/2006 (ref: EK 06-058-VK)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
The participants were randomised to either the intervention or control group:
Intervention group: 12 weeks outdoor Nordic walking exercise programme (1 hour per session, 3 times/week)
Control group: no exercise intervention
Patients randomised to the intervention group trained 3 times a week for 1 hour at recommended 75% of their initial maximum heart frequency obtained during initial maximum exercise test. In addition, the participants in the intervention group attended 1 hour/week educational sessions on pulmonary pathophysiology, management of breathlessness and exacerbations, clearance of pulmonary secretions, smoking cessation, medication and nutrition.
The control group received 1 hour/month educational sessions.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Functional exercise capacity, assessed using the six minute walking test (6MWT).
All primary and secondary outcome measures will be assessed at baseline and after 3, 6, and 9 month.
Secondary outcome measures
1. Daily physical activities, assessed using a tri-axial accelerometer (DynaPort® Activity Monitor; McRoberts BV, Netherlands)
2. Exercise-induced dyspnoea, assessed using the modified Borg Dyspnoea Scale
3. Mood status, assessed using the Hospital Anxiety and Depression Scale (HADS)
All primary and secondary outcome measures will be assessed at baseline and after 3, 6, and 9 month.
Overall trial start date
01/03/2006
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age >18 years
2. Stable COPD (no infection or exacerbation for at least 12 weeks)
3. Absence of severe and/or unstable cardiac diseases (myocardial infarction within the last 6 month, cardiac arrhythmia Lown classification >IIIb, as shown by electrocardiogram during rest and maximal exercise test)
4. Absence of other pathologic conditions that could impair daily physical activities (cerebrovascular diseases, rheumatism, symptomatic osteoporosis and others)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/03/2006
Recruitment end date
01/03/2007
Locations
Countries of recruitment
Austria
Trial participating centre
Ludwig Boltzmann Institue for COPD
Vienna
1140
Austria
Sponsor information
Organisation
Ludwig Boltzmann Institute for COPD (Ludwid Boltzmann Institut für COPD) (Austria)
Sponsor details
Sanatoriumstrasse 2
Vienna
1140
Austria
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Ludwig Boltzmann Institute for COPD (Ludwid Boltzmann Institut für COPD) (Austria) - http://www.lbg.ac.at
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary