Empowerment of Lung and Heart-lung Transplant Patients

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00808600
• Other study ID #: IFB-application 32
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2008
• Last updated: August 18, 2009
• Start date: October 2009
• Est. completion date: January 2014

Study information

• Verified date: August 2009
• Source: Hannover Medical School
• Contact: Janina Bronisch-Holtze, Dipl.-Psych.
• Phone: 0049-511-532-3133
• Email: bronisch-holtze.janina[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exercise Training
• Heart-Lung Transplantation
• Lung Transplantation
• Psychotherapy
• Rehabilitation

Intervention

Behavioral:
• resource-activating behavioural training programme
Stepwise intervention based on the principles of resource-activating training (RAT) applied to the needs of patients in the process after lung transplantation. Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Continued resource-activation and transfer by means of internet-based interventions (1 per 2 weeks) as well as personal interventions by trained nurses and a clinical psychologist during regular out-patient visits (approx. 4 times per year) over one year immediately following rehabilitation. Interventions focus on strengthening individual and interpersonal resources for well-being, psychoeducation, stress management and coping with illness. Phase 3: Termination and transfer, including a detailed medical report.
• Relaxation training
Phase 1: Build-up of therapeutic relationship through resource-activating training for patients after transplantation during rehabilitation in the rehabilitation centre Fallingbostel following inpatient treatment. Phase 2: Regular relaxation training after rehabilitation by self-guided relaxation compact disk and accompanying worksheets.
• Intensified anaerobic exercise training
Phase 1: Recruitment and initiation of intensified and individualised aerobic/anaerobic exercise training based on determination of aerobic/anaerobic threshold during rehabilitation in the rehabilitation centre Fallingbostel. During rehabilitation daily training sessions with a duration of 30 minutes each are performed under medical supervision. Phase 2: Home training on an IT-assisted ergometer 3.5 times a week with interval exercise intensity above the anaerobic threshold. Work load and heart rate are stored by an ergometer-chip, lung function analyses are performed and should be transferred via phone-based telemetry. Exercise training intensities will be adapted monthly, corresponding to training results. At regular 3 months visits to the outpatient clinic a medical examination is carried out. Moreover, according to the actual functional state of the patient estimated 3 monthly training work load will be adjusted. Phase 3: Termination, evaluation after a period of 12 months.
• Moderate aerobic exercise training
Phase 1: Recruitment and initiation of moderate aerobic exercise training based on 40 percent of maximal oxygen consumption in Watt during rehabilitation in the rehabilitation centre Fallingbostel. Phase 2: Moderate aerobic endurance training with the target intensity of 40 percent of the individual maximum exercise capacity will be performed 3.5 times a week with a duration of 30 minutes per session, work load will be adapted continuously according to the measures that are assessed during the repeated control examinations after periods of 3 months in the outpatient clinic of the pulmonary department of Hanover Medical School.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (16)

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

Outcome

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