Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA

NCT01393327 | Completed

• 1 other identifier: S-488/2009
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study is to investigate whether and to what extent a cautious respiratory and movement therapy can complement medical treatment and the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.

Conditions

CTEPH

Keywords

physical training; remaining post-operative pulmonary vascular changes; right ventricular pump function; PEA

Outcome Measures

Primary Outcomes (2)

• Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA

  Assessment of feasibility and tolerance of exercise rehabilitation directly after PEA assessed by the number of patients completing the exercise rehabilitation program

  up to 15 weeks after start of rehabilitation with exercise training

• Change of peak O2 uptake (VO2peak) during exercise

  Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)

  up to 15 weeks after start of rehabilitation with exercise training

Secondary Outcomes (28)

• Change in right atrial pressure (RAP) at rest

  up to 15 weeks after start of rehabilitation with exercise training

• Change in right atrial pressure (RAP) during exercise

  up to 15 weeks after start of rehabilitation with exercise training

• Change in right ventricular pressure (RVP) at rest

  up to 15 weeks after start of rehabilitation with exercise training

• Change in right ventricular pressure (RVP) during exercise

  up to 15 weeks after start of rehabilitation with exercise training

• Change in systolic pulmonary arterial pressure (sPAP) at rest

  up to 15 weeks after start of rehabilitation with exercise training

Study Arms (1)

Respiratory and exercise therapy

EXPERIMENTAL

Early after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks.

Behavioral: respiratory and exercise therapy

Interventions

respiratory and exercise therapy BEHAVIORAL

Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training

Respiratory and exercise therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent form
• men and women\> 18 years \<80 years
• CTEPH after pulmonary endarterectomy

You may not qualify if:

• Patients with signs of right heart decompensation
• acute diseases, infections, fever
• Serious lung disease with FEV1 \<50% or TLC \<70% of target

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

Location

Related Publications (29)

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  PMID: 25438215 RESULT

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  PMID: 32726793 DERIVED

MeSH Terms

Interventions

Respiratory Rate; Exercise Therapy

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ekkehard Grünig, Professor

  Center for pulmonary hypertension, Thoraxclinic Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 13, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

DE (1)