Condition category
Circulatory System
Date applied
27/05/2010
Date assigned
15/07/2010
Last edited
15/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland

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

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

University Hospital Basel
Pneumology
Petersgraben 4
Basel
4031
Switzerland

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes