Please select the eligibility criteria that correspond to the clinical trial below.
Title: Empowerment of Lung and Heart-lung Transplant Patients by a Multimodal Resource-activating Behavioural Training Programme and Cardiopulmonary Exercise - a Randomised Controlled Study
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.


Options:
A: Inclusion Criteria:

* 18 years of age or older

  -\>4 weeks after the participant had lung transplant surgery
* Discharged from the hospital after your lung transplant surgery
* MD report of difficulty walking ¼ mile or climbing 10 steps without resting
* Medical monitor approves patient eligibility for participation

Exclusion Criteria:

* concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period with no plans to stop formal exercise
* having other chronic conditions that may severely limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments
* does not have home internet or smart device with Bluetooth capabilities
* medical issue precluding participation
* declining to be asked screening questions, or declining an introduction to the research team to hear about research
* greater than 18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)
B: Inclusion Criteria:

* Lung transplant (single, double, combined heart-lung) (6-9 mts post Tx)
* Stable health condition at study entry (pt stays within home environment)
* Age ≥ 18 yrs
* Sufficient language skills to answer questionnaire
* Follow-up at our center
* Willingness to participate by written informed consent

Exclusion Criteria:

* BOS III diagnosis before study inclusion
* Episodes of recurrent acute rejections
* Medical contra-indication for regular exercise ergometer training
* Malignancy
* Multi-resistent pathogens
C: Inclusion Criteria:

* Recipients of single or double lung transplants

Exclusion Criteria:

* Recipients of multiple organ transplants
* Patients scheduled for retransplantation
* Patients not leaving hospital within 6 weeks after surgery
D: 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

Answer: D