Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00808600
Status:
UNKNOWN
Last Update Posted:
2009-08-19
First Post:
2008-12-15
Brief Title:
Empowerment of Lung and Heart-lung Transplant Patients
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None