Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

NCT01394367 | Completed

• 1 other identifier: S-472/2009
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change 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

Pulmonary Hypertension

Keywords

respiratory therapy; exercise therapy; oxygen uptake; quality of life; right ventricular function; severe pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Improvement of peak O2 uptake (VO2peak) under stress

  Three-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group.

  up to 15 weeks

Secondary Outcomes (1)

• Changes in hemodynamics at rest and during exercise

  up to 15 weeks

Study Arms (2)

Respiratory and exercise therapy

EXPERIMENTAL

Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.

Other: respiratory and exercise therapy

respiratory and exercise therapy

NO INTERVENTION

Interventions

respiratory and exercise therapy OTHER

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 - 75 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 \<75 years
• invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

You may not qualify if:

• Pregnancy or lactation
• Change in medication during the last 2 months
• Patients with signs of right heart decompensation
• severe walking disturbance
• uncertain diagnoses
• No previous invasively confirmation of PH
• 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

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Respiratory Rate; Exercise Therapy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

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: RANDOMIZED
• 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 14, 2011
• Study Start: June 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

DE (1)