Empowerment of Lung and Heart-lung Transplant Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hannover Medical School.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00808600
First received: December 15, 2008
Last updated: August 18, 2009
Last verified: August 2009

December 15, 2008
August 18, 2009
October 2009
July 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00808600 on ClinicalTrials.gov Archive Site
  • St. George Respiratory Questionnaire (SGRQ) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ] [ Designated as safety issue: Yes ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ] [ Designated as safety issue: Yes ]
  • Social Support Questionnaire (F-SozU) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ] [ Designated as safety issue: Yes ]
  • Life Orientation Test (LOT) [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • other variables of functional status [ Time Frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Empowerment of Lung and Heart-lung Transplant Patients
Empowerment of Lung and Heart-lung Transplant Patients by a Multimodal Resource-activating Behavioural Training Programme and Cardiopulmonary Exercise - a Randomised Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Transplantation
  • Heart-Lung Transplantation
  • "Rehabilitation"
  • Psychotherapy
  • 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: 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.
  • 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.
  • resource-activating training, intensified exercise training
    combination of the two interventions: resource-activating behavioural training and intensified exercise training
    Interventions:
    • Behavioral: resource-activating behavioural training programme
    • Behavioral: Intensified anaerobic exercise training
  • resource-activating training, moderate exercise training
    combination of the two interventions: resource-activating training and moderate exercise training
    Interventions:
    • Behavioral: resource-activating behavioural training programme
    • Behavioral: Moderate aerobic exercise training
  • relaxation training, intensified exercise training
    combination of the two interventions: relaxation training and intensified exercise training
    Interventions:
    • Behavioral: Relaxation training
    • Behavioral: Intensified anaerobic exercise training
  • relaxation training, moderate exercise training
    combination of the two interventions: relaxation training and moderate exercise training
    Interventions:
    • Behavioral: Relaxation training
    • Behavioral: Moderate aerobic exercise training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
132
January 2014
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 68 Years
No
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
Germany
 
NCT00808600
IFB-application 32
No
Prof. Dr. Harald Guendel, Department of Psychosomatics and Psychotherapy, Hannover Medical School
Hannover Medical School
Not Provided
Principal Investigator: Harald Gündel, Prof. Dr. Dept. of Psychosomatics and Psychotherapy, Hannover Medical School
Hannover Medical School
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP