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.
Status | Not yet recruiting |
Enrollment | 132 |
Est. completion date | January 2014 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 68 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School | Hannover |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Ambrosino N, Strambi S. New strategies to improve exercise tolerance in chronic obstructive pulmonary disease. Eur Respir J. 2004 Aug;24(2):313-22. Review. — View Citation
Blumenthal JA, Babyak MA, Keefe FJ, Davis RD, Lacaille RA, Carney RM, Freedland KE, Trulock E, Palmer SM. Telephone-based coping skills training for patients awaiting lung transplantation. J Consult Clin Psychol. 2006 Jun;74(3):535-44. — View Citation
De Vito Dabbs A, Hoffman LA, Swigart V, Happ MB, Dauber JH, McCurry KR, Iacono A. Striving for normalcy: symptoms and the threat of rejection after lung transplantation. Soc Sci Med. 2004 Oct;59(7):1473-84. — View Citation
Dew MA, DiMartini AF. Psychological disorders and distress after adult cardiothoracic transplantation. J Cardiovasc Nurs. 2005 Sep-Oct;20(5 Suppl):S51-66. Review. — View Citation
Dew MA, Goycoolea JM, Harris RC, Lee A, Zomak R, Dunbar-Jacob J, Rotondi A, Griffith BP, Kormos RL. An internet-based intervention to improve psychosocial outcomes in heart transplant recipients and family caregivers: development and evaluation. J Heart Lung Transplant. 2004 Jun;23(6):745-58. — View Citation
Dew MA, Kormos RL, DiMartini AF, Switzer GE, Schulberg HC, Roth LH, Griffith BP. Prevalence and risk of depression and anxiety-related disorders during the first three years after heart transplantation. Psychosomatics. 2001 Jul-Aug;42(4):300-13. — View Citation
Gimenez M, Servera E, Vergara P, Bach JR, Polu JM. Endurance training in patients with chronic obstructive pulmonary disease: a comparison of high versus moderate intensity. Arch Phys Med Rehabil. 2000 Jan;81(1):102-9. — View Citation
Hentschel M, Becker J, Lepthin HJ. [Effects of a high intensity training program on patients with chronic obstructive airways disease (COAD)]. Pneumologie. 2002 Apr;56(4):240-6. German. — View Citation
Kugler C, Fischer S, Gottlieb J, Welte T, Simon A, Haverich A, Strueber M. Health-related quality of life in two hundred-eighty lung transplant recipients. J Heart Lung Transplant. 2005 Dec;24(12):2262-8. Epub 2005 Nov 17. — View Citation
Lanuza DM, Lefaiver C, Mc Cabe M, Farcas GA, Garrity E Jr. Prospective study of functional status and quality of life before and after lung transplantation. Chest. 2000 Jul;118(1):115-22. — View Citation
Linden W, Phillips MJ, Leclerc J. Psychological treatment of cardiac patients: a meta-analysis. Eur Heart J. 2007 Dec;28(24):2972-84. Epub 2007 Nov 5. Review. — View Citation
Mathur S, Reid WD, Levy RD. Exercise limitation in recipients of lung transplants. Phys Ther. 2004 Dec;84(12):1178-87. Review. — View Citation
Napolitano MA, Babyak MA, Palmer S, Tapson V, Davis RD, Blumenthal JA; Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE) Investigators. Effects of a telephone-based psychosocial intervention for patients awaiting lung transplantation. Chest. 2002 Oct;122(4):1176-84. — View Citation
Oelberg DA, Systrom DM, Markowitz DH, Zorb SL, Wright C, Wain JC, Ginns LC. Exercise performance in cystic fibrosis before and after bilateral lung transplantation. J Heart Lung Transplant. 1998 Nov;17(11):1104-12. — View Citation
Tegtbur U, Busse MW, Jung K, Pethig K, Haverich A. Time course of physical reconditioning during exercise rehabilitation late after heart transplantation. J Heart Lung Transplant. 2005 Mar;24(3):270-4. — View Citation
Van Der Woude BT, Kropmans TJ, Douma KW, Van Der Bij W, Ouwens JP, Koeter GH, Van Der Schans CP. Peripheral muscle force and exercise capacity in lung transplant candidates. Int J Rehabil Res. 2002 Dec;25(4):351-5. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SF-36 Physical and Psychological Component Summary | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Primary | Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Primary | Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Primary | Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | St. George Respiratory Questionnaire (SGRQ) | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | Social Support Questionnaire (F-SozU) | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | Life Orientation Test (LOT) | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | Compliance to medical treatment, exercise training, and lung function measurements at patients' home by an asthma monitor | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes | |
Secondary | other variables of functional status | T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up | Yes |
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