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Empowerment of Lung and Heart-lung Transplant Patients

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ClinicalTrials.gov Identifier: NCT00808600
Recruitment Status : Unknown
Verified August 2009 by Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : December 16, 2008
Last Update Posted : August 19, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

Lung or combined heart-lung transplantation represents an established treatment strategy for patients with end-stage lung disease. Transplantation results in an increased exercise capacity, a better quality of life and - depending on the pulmonary disease - a prolonged life compared to the natural course of the pulmonary disease. However, even after successful organ transplantation, patients realise the often inflated, unrealistic character of their previous expectations due to their continuing dependence on medication, regular control examinations and a higher risk of infections and allograft rejections. Patients have to cope with erupting demands in family, social and work life. It becomes evident that their lives have changed forever. In this context, limitations in mental health like depression and reduced quality of life (QoL) as well as diminished compliance may emerge or even persist. By five years post-transplant, about one-half of the patients meet the criteria of an anxiety disorder. Symptoms of a clinically relevant depression or mood disorder occur in 10 to 15 % of lung transplant patients.

In addition, patients after lung transplantation are often in a poor physical condition and only hold a reduced functional status. Surgery itself, a prolonged weaning period during mechanical ventilation, sepsis, and especially the immunosuppressive medication may long-ranging or permanently limit physical activity, further reducing muscle mass and bodily function.

Some positive effects of either psychological coping skills training or supervised exercise therapy after lung or heart-lung transplantation on QoL and functional status have been described in very few existing pilot studies with small numbers of patients and only short-term follow-up. In addition, although clear evidence points to a mutual amplifying effect of both psychological training and exercise therapy in patients coping with chronic disease, no such study has yet been conducted in the transplantation field.

Therefore, the aim of the investigators randomised controlled study is to prove the differential benefit of a multi-modal resource-activating behavioural training programme combined with an intensified exercise training programme on functional status as well as on QoL in a four-armed design. The investigators hypotheses are: (H1) The multimodal resource-activating behavioural training programme will show better out-comes in the measures of global health-related QoL compared to a relaxation group. (H2) Participants in the intensified anaerobic exercise training will have better outcomes in the measures of exercise-related variables and lung function than the group with moderate aerobic exercise training. (H3) Participants in the behavioural intervention programme and the intensified exercise training will have better outcomes in the measures of global health-related QoL and exercise-related variables compared to the other groups.


Condition or disease Intervention/treatment
Lung Transplantation Heart-Lung Transplantation "Rehabilitation" Psychotherapy Exercise Training Behavioral: resource-activating behavioural training programme Behavioral: Relaxation training Behavioral: Intensified anaerobic exercise training Behavioral: Moderate aerobic exercise training

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empowerment of Lung and Heart-lung Transplant Patients by a Multimodal Resource-activating Behavioural Training Programme and Cardiopulmonary Exercise - a Randomised Controlled Study
Study Start Date : October 2009
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
resource-activating training, intensified exercise training
combination of the two interventions: resource-activating behavioural training and intensified exercise training
Behavioral: resource-activating behavioural training programme

Stepwise intervention based on the principles of resource-activating training (RAT) applied to the needs of patients in the process after lung transplantation.

Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Continued resource-activation and transfer by means of internet-based interventions (1 per 2 weeks) as well as personal interventions by trained nurses and a clinical psychologist during regular out-patient visits (approx. 4 times per year) over one year immediately following rehabilitation. Interventions focus on strengthening individual and interpersonal resources for well-being, psychoeducation, stress management and coping with illness. Phase 3: Termination and transfer, including a detailed medical report.

Behavioral: Intensified anaerobic exercise training
Phase 1: Recruitment and initiation of intensified and individualised aerobic/anaerobic exercise training based on determination of aerobic/anaerobic threshold during rehabilitation in the rehabilitation centre Fallingbostel. During rehabilitation daily training sessions with a duration of 30 minutes each are performed under medical supervision. Phase 2: Home training on an IT-assisted ergometer 3.5 times a week with interval exercise intensity above the anaerobic threshold. Work load and heart rate are stored by an ergometer-chip, lung function analyses are performed and should be transferred via phone-based telemetry. Exercise training intensities will be adapted monthly, corresponding to training results. At regular 3 months visits to the outpatient clinic a medical examination is carried out. Moreover, according to the actual functional state of the patient estimated 3 monthly training work load will be adjusted. Phase 3: Termination, evaluation after a period of 12 months.
resource-activating training, moderate exercise training
combination of the two interventions: resource-activating training and moderate exercise training
Behavioral: resource-activating behavioural training programme

Stepwise intervention based on the principles of resource-activating training (RAT) applied to the needs of patients in the process after lung transplantation.

Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Continued resource-activation and transfer by means of internet-based interventions (1 per 2 weeks) as well as personal interventions by trained nurses and a clinical psychologist during regular out-patient visits (approx. 4 times per year) over one year immediately following rehabilitation. Interventions focus on strengthening individual and interpersonal resources for well-being, psychoeducation, stress management and coping with illness. Phase 3: Termination and transfer, including a detailed medical report.

Behavioral: Moderate aerobic exercise training
Phase 1: Recruitment and initiation of moderate aerobic exercise training based on 40 percent of maximal oxygen consumption in Watt during rehabilitation in the rehabilitation centre Fallingbostel. Phase 2: Moderate aerobic endurance training with the target intensity of 40 percent of the individual maximum exercise capacity will be performed 3.5 times a week with a duration of 30 minutes per session, work load will be adapted continuously according to the measures that are assessed during the repeated control examinations after periods of 3 months in the outpatient clinic of the pulmonary department of Hanover Medical School.
relaxation training, intensified exercise training
combination of the two interventions: relaxation training and intensified exercise training
Behavioral: Relaxation training
Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Regular relaxation training after rehabilitation by self-guided relaxation compact disk and accompanying worksheets.
Behavioral: Intensified anaerobic exercise training
Phase 1: Recruitment and initiation of intensified and individualised aerobic/anaerobic exercise training based on determination of aerobic/anaerobic threshold during rehabilitation in the rehabilitation centre Fallingbostel. During rehabilitation daily training sessions with a duration of 30 minutes each are performed under medical supervision. Phase 2: Home training on an IT-assisted ergometer 3.5 times a week with interval exercise intensity above the anaerobic threshold. Work load and heart rate are stored by an ergometer-chip, lung function analyses are performed and should be transferred via phone-based telemetry. Exercise training intensities will be adapted monthly, corresponding to training results. At regular 3 months visits to the outpatient clinic a medical examination is carried out. Moreover, according to the actual functional state of the patient estimated 3 monthly training work load will be adjusted. Phase 3: Termination, evaluation after a period of 12 months.
relaxation training, moderate exercise training
combination of the two interventions: relaxation training and moderate exercise training
Behavioral: Relaxation training
Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Regular relaxation training after rehabilitation by self-guided relaxation compact disk and accompanying worksheets.
Behavioral: Moderate aerobic exercise training
Phase 1: Recruitment and initiation of moderate aerobic exercise training based on 40 percent of maximal oxygen consumption in Watt during rehabilitation in the rehabilitation centre Fallingbostel. Phase 2: Moderate aerobic endurance training with the target intensity of 40 percent of the individual maximum exercise capacity will be performed 3.5 times a week with a duration of 30 minutes per session, work load will be adapted continuously according to the measures that are assessed during the repeated control examinations after periods of 3 months in the outpatient clinic of the pulmonary department of Hanover Medical School.


Outcome Measures

Primary Outcome Measures :
  1. SF-36 Physical and Psychological Component Summary [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  2. Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  3. Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  4. Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]

Secondary Outcome Measures :
  1. St. George Respiratory Questionnaire (SGRQ) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  2. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  3. Social Support Questionnaire (F-SozU) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  4. Life Orientation Test (LOT) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  5. Compliance to medical treatment, exercise training, and lung function measurements at patients' home by an asthma monitor [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]
  6. other variables of functional status [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All individuals following lung or combined heart-lung transplantation at Hanover Medical School

Exclusion Criteria:

  • Severe bronchus stenosis after surgery
  • Uncontrolled hypertension
  • Orthopedic impairment
  • Oxygen desaturation during exercise to less than 89 % without supplemental oxygen
  • Cardiovascular complications that limit exercise tolerance
  • Persistent multi-drug resistant infections (MRSA, VRE, Burkholderia Cepacia, Pandorea)
  • Severe psychiatric disorders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808600


Contacts
Contact: Janina Bronisch-Holtze, Dipl.-Psych. 0049-511-532-3133 bronisch-holtze.janina@mh-hannover.de
Contact: Harald Gündel, Prof. Dr. 0049-511-532-6569 guendel.harald@mh-hannover.de

Locations
Germany
Hannover Medical School Not yet recruiting
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
Principal Investigator: Harald Gündel, Prof. Dr. Dept. of Psychosomatics and Psychotherapy, Hannover Medical School
More Information

Publications:

Responsible Party: Prof. Dr. Harald Guendel, Department of Psychosomatics and Psychotherapy, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00808600     History of Changes
Other Study ID Numbers: IFB-application 32
First Posted: December 16, 2008    Key Record Dates
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by Hannover Medical School:
lung transplantation
heart-lung transplantation
rehabilitation
resource-activating training
anaerobic exercise training