Comparison of two physiotherapy rehabilitation programmes on the exercise capacity in patients with severe pulmonary hypertension
| ISRCTN | ISRCTN06900747 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06900747 |
| Secondary identifying numbers | EKBB 200/09 |
- Submission date
- 27/05/2010
- Registration date
- 15/07/2010
- Last edited
- 15/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daiana Stolz
Scientific
Scientific
University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland
Study information
| Study design | Prospective randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | Comparison of two physiotherapy rehabilitation programmes on the exercise capacity in patients with severe pulmonary hypertension: a randomised study |
| Study acronym | Rehab PH |
| Study objectives | An endurance or/and resistance training improves the exercise capacity and quality of life of patients with severe pulmonary hypertension |
| Ethics approval(s) | The local ethics committee, Basel, Switzerland approved in June 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2010 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 30/06/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
University/education
University/education
University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland
"ROR" |
https://ror.org/04k51q396 |
|---|
Funders
Funder type
Hospital/treatment centre
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research (from research funds of Prof M Tamm)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
