Clinical trial NCT00808600: Empowerment of Lung and Heart-lung Transplant Patients
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplantation
Heart-Lung Transplantation
"Rehabilitation"
Psychotherapy
Exercise Training
Keywords: lung transplantation
heart-lung transplantation
rehabilitation
resource-activating training
anaerobic exercise training
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2008-12-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: SF-36 Physical and Psychological Component Summary
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Secondary outcomes:
measure: St. George Respiratory Questionnaire (SGRQ)
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Social Support Questionnaire (F-SozU)
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Life Orientation Test (LOT)
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: Compliance to medical treatment, exercise training, and lung function measurements at patients' home by an asthma monitor
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
measure: other variables of functional status
timeFrame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Dept. of Psychosomatics and Psychotherapy, Hannover Medical School
name: Harald Gündel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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