Please select the arm or intervention descriptions that belong 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: Arm Label: LTGO-Home Based Exercise; Type: EXPERIMENTAL; Interventions: Behavioral: LTGO-Home Based Exercise | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: LTGO-Home Based Exercise; Assigned to Arm(s): LTGO-Home Based Exercise | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care
B: Intervention Type: BEHAVIORAL; Name: exercise training; psychosocial support; Assigned to Arm(s): N/A
C: Arm Label: Rehabilitation + Lifestyle Counseling; Type: EXPERIMENTAL; Interventions: Procedure: Rehabilitation including structured exercise training | Arm Label: Lifestyle Counseling; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Physical Activity Counseling | Intervention Type: PROCEDURE; Name: Rehabilitation including structured exercise training; Assigned to Arm(s): Rehabilitation + Lifestyle Counseling | Intervention Type: PROCEDURE; Name: Physical Activity Counseling; Assigned to Arm(s): Lifestyle Counseling
D: Arm Label: resource-activating training, intensified exercise training; Type: OTHER; Interventions: Behavioral: resource-activating behavioural training programme, Behavioral: Intensified anaerobic exercise training | Arm Label: resource-activating training, moderate exercise training; Type: OTHER; Interventions: Behavioral: resource-activating behavioural training programme, Behavioral: Moderate aerobic exercise training | Arm Label: relaxation training, intensified exercise training; Type: OTHER; Interventions: Behavioral: Relaxation training, Behavioral: Intensified anaerobic exercise training | Arm Label: relaxation training, moderate exercise training; Type: OTHER; Interventions: Behavioral: Relaxation training, Behavioral: Moderate aerobic exercise training | Intervention Type: BEHAVIORAL; Name: resource-activating behavioural training programme; Assigned to Arm(s): resource-activating training, intensified exercise training, resource-activating training, moderate exercise training | Intervention Type: BEHAVIORAL; Name: Relaxation training; Assigned to Arm(s): relaxation training, intensified exercise training, relaxation training, moderate exercise training | Intervention Type: BEHAVIORAL; Name: Intensified anaerobic exercise training; Assigned to Arm(s): relaxation training, intensified exercise training, resource-activating training, intensified exercise training | Intervention Type: BEHAVIORAL; Name: Moderate aerobic exercise training; Assigned to Arm(s): relaxation training, moderate exercise training, resource-activating training, moderate exercise training

Answer: D