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
Protocol serial number	EKBB 200/09
Sponsor	University Hospital Basel (Switzerland)
Funder	University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research (from research funds of Prof M Tamm)

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

Prof Daiana Stolz
Scientific

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland

Primary study design	Interventional
Study design	Prospective randomised interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Change in walking distance (6-minutes walk test) after 12 weeks of training and 12 weeks follow up
Key secondary outcome measure(s)	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
Completion date	30/06/2012

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

University Hospital Basel

Basel
4031
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes