Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EKBB 200/09
Study information
Scientific title
Comparison of two physiotherapy rehabilitation programmes on the exercise capacity in patients with severe pulmonary hypertension: a randomised study
Acronym
Rehab PH
Study hypothesis
An endurance or/and resistance training improves the exercise capacity and quality of life of patients with severe pulmonary hypertension
Ethics approval
The local ethics committee, Basel, Switzerland approved in June 2009
Study design
Prospective randomised interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Pulmonary hypertension
Intervention
Intervention group 1: - endurance training: twice a week, 60 minutes, over 12 weeks
Intervention group 2: - resistance training: twice a week, 60 minutes, over 12 weeks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Change in walking distance (6-minutes walk test) after 12 weeks of training and 12 weeks follow up
Secondary outcome measures
1. Change in VO2 submax (mobile spiroergometry) after 12 weeks of training and 12 weeks follow up
2. Change in scores for quality of life (SF-36 questionnaire) after 12 weeks of training and 12 weeks follow up
3. Change in scores (MRC-Dyspnoea scale) after 12 weeks of training and 12 weeks follow up
4. Change in daily activity measured with an accelerometer AiperMotion 320 after 12 weeks of training and 12 weeks follow up
Overall trial start date
01/07/2010
Overall trial end date
30/06/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with pulmonary hypertension diagnosed by right heart catheterisation (mean pulmonary pressure [PAPm] > 25 mmHg)
2. New York Heart Association (NYHA) III - V
3. Walking distance (6-minutes walk test) > 150 meters
4. Patients with stable conditions on PH-related medication (single, double or triple therapy)
5. In stable condition for at least 3 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36
Participant exclusion criteria
1. Skeletal or muscular restrictions which make the training impossible
2. New occurrence of syncope
3. Concomitant neurological diseases
4. Patients with neoplastic diseases
5. Mental disability making a proper evaluation of the study impossible
6. Age > 18 years < 85
7. Rapid fatal disease
Recruitment start date
01/07/2010
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Basel
Basel
4031
Switzerland
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research (from research funds of Prof M Tamm)
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