1. Does exercise training improve muscle function and exercise tolerance in patients with IPAH?2. Does exercise training in IPAH result in morphological and biochemical changes of the quadriceps muscle?3. Does exercise training in IPAH result in…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Pulmonary vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters:
- Change in strength and endurance of the quadriceps muscles
- Change in exercise tolerance
- Change in biochemical and morphological characteristics of the quadriceps
muscles
Secondary outcome
not applicable
Background summary
Patients with pulmonary arterial hypertension (PAH) suffer from muscle fatigue
and dyspnoea. Due to right ventricular dysfunction and thereby the inability to
increase cardiac output during exercise, there is decreased perfusion of the
lung and reduced ability to adapt to peripheral oxygen demand. As a
consequence, patients with PAH have reduced ventilatory efficiency and early
muscle fatigue. Therefore, the question whether muscle dysfunction in PAH is
primarily the result of disuse rather than a true myopathy needs to be
answered. Biopsies of the vastus lateralis will provide information on the
morphological and biochemical changes after exercise training and gives the
opportunity to differentiate between deconditioning or a true myopathy.
Study objective
1. Does exercise training improve muscle function and exercise tolerance in
patients with IPAH?
2. Does exercise training in IPAH result in morphological and biochemical
changes of the quadriceps muscle?
3. Does exercise training in IPAH result in increased muscle mass?
4. Can IPAH patients who show a positive response to exercise training be
distinguished on base of clinical parameters or specific muscle
characteristics?
Study design
Study design:
In 20 patients with idiopathic pulmonary hypertension, the effect of exercise
training on exercise tolerance, quadriceps function and quality of live will be
assessed. Before and after a training period of 3 months, quadriceps function,
exercise tolerance and quality of life will be measured. Moreover, a biopsy of
the quadriceps muscles will be performed to characterize possible morphological
and biochemical changes.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
Blood samples and quadriceps biopsies will be taken before and after the
training period at the VU medical centre. Moreover, all prior-exercise tests
will take place in Amsterdam. It is tried to combine these visits with routine
appointments at the hospital. Moreover, patients will be admitted to the
hospital after the biopsy. To minimize the burden of travelling three times a
week to the hospital, exercise training will take place at a rehabilitation
centre nearby the homes of the patients.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
- Mean pulmonary artery pressure (mPAP) > 25 mmHg
- Stable on therapy for at least 3 months
- Idiopathic pulmonary arterial hypertension
Exclusion criteria
- Presence of systemic inflammation
- Patients with pulmonary hypertension associated with collagen vascular disease, congenital heart disease, chronic thrombo-embolic pulmonary hypertension, pulmonary venous hypertension, left heart failure, hypoxemic lung disease
- Patients with musculoskeletal problems prohibiting maximal exercise performance
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL11636.029.06 |