Rehabilitation Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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