Lung TransplantationNCT00808600
Empowerment of Lung and Heart-lung Transplant Patients
A study testing resource-activating behavioural training programme, Relaxation training and Intensified anaerobic exercise training in people with Lung Transplantation and Heart-Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Lung Transplantation, Heart-Lung Transplantation, "Rehabilitation"
- What is being tested?
- resource-activating behavioural training programme, Relaxation training and Intensified anaerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals following lung or combined heart-lung transplantation at Hanover Medical School
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Lung Transplantation, Heart-Lung Transplantation, "Rehabilitation", Psychotherapy, Exercise Training
- Being tested
- resource-activating behavioural training programme, Relaxation training, Intensified anaerobic exercise training, Moderate aerobic exercise training
- Keywords
- lung transplantation, heart-lung transplantation, rehabilitation, resource-activating training, anaerobic exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resource-activating behavioural training programmeBehavioural
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 trainingBehavioural
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 trainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| resource-activating training, intensified exercise training | Other | combination of the two interventions: resource-activating behavioural training and intensified exercise training Receives: Behavioral: resource-activating behavioural training programme; Behavioral: Intensified anaerobic exercise training |
| resource-activating training, moderate exercise training | Other | combination of the two interventions: resource-activating training and moderate exercise training Receives: Behavioral: resource-activating behavioural training programme; Behavioral: Moderate aerobic exercise training |
| relaxation training, intensified exercise training | Other | combination of the two interventions: relaxation training and intensified exercise training Receives: Behavioral: Relaxation training; Behavioral: Intensified anaerobic exercise training |
| relaxation training, moderate exercise training | Other | combination of the two interventions: relaxation training and moderate exercise training Receives: Behavioral: Relaxation training; Behavioral: Moderate aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Physical and Psychological Component Summary
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Secondary outcomes (6)
St. George Respiratory Questionnaire (SGRQ)
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Hospital Anxiety and Depression Scale (HADS)
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Social Support Questionnaire (F-SozU)
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Life Orientation Test (LOT)
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Compliance to medical treatment, exercise training, and lung function measurements at patients' home by an asthma monitor
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
other variables of functional status
Measured: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startOct 2009
- Primary completionJul 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Harald Gündel, Prof. Dr., Principal investigator, Dept. of Psychosomatics and Psychotherapy, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808600
- Sponsor's protocol ID
- IFB-application 32
- Status last verified
- Aug 2009
- First submitted
- 15 Dec 2008
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ambrosino N, Strambi S. New strategies to improve exercise tolerance in chronic obstructive pulmonary disease. Eur Respir J. 2004 Aug;24(2):313-22. doi: 10.1183/09031936.04.00002904.
PubMed 15332404Blumenthal 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. doi: 10.1037/0022-006X.74.3.535.
PubMed 16822110De 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. doi: 10.1016/j.socscimed.2004.01.013.
PubMed 15246175Dew MA, DiMartini AF. Psychological disorders and distress after adult cardiothoracic transplantation. J Cardiovasc Nurs. 2005 Sep-Oct;20(5 Suppl):S51-66. doi: 10.1097/00005082-200509001-00007.
PubMed 16160585Dew 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. doi: 10.1016/j.healun.2003.07.002.
PubMed 15366436Dew 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. doi: 10.1176/appi.psy.42.4.300.
PubMed 11496019Gimenez 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. doi: 10.1016/s0003-9993(00)90229-6.
PubMed 10638884Hentschel 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. doi: 10.1055/s-2002-25073. German.
PubMed 11951158Kugler 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. doi: 10.1016/j.healun.2005.07.005. Epub 2005 Nov 17.
PubMed 16364880Lanuza 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. doi: 10.1378/chest.118.1.115.
PubMed 10893368Linden W, Phillips MJ, Leclerc J. Psychological treatment of cardiac patients: a meta-analysis. Eur Heart J. 2007 Dec;28(24):2972-84. doi: 10.1093/eurheartj/ehm504. Epub 2007 Nov 5.
PubMed 17984133Mathur S, Reid WD, Levy RD. Exercise limitation in recipients of lung transplants. Phys Ther. 2004 Dec;84(12):1178-87. No abstract available.
PubMed 15563258Napolitano 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. doi: 10.1378/chest.122.4.1176.
PubMed 12377839Oelberg 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.
PubMed 9855450Tegtbur 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. doi: 10.1016/j.healun.2003.12.010.
PubMed 15737752
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00808600
- Acronym / sponsor ID
- IFB-application 32
- Conditions
- Lung Transplantation, Heart-Lung Transplantation, "Rehabilitation", Psychotherapy, Exercise Training
- Keywords
- lung transplantation, heart-lung transplantation, rehabilitation, resource-activating training, anaerobic exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| resource-activating training, intensified exercise training | Other | Behavioral: resource-activating behavioural training programme, Behavioral: Intensified anaerobic exercise trainingcombination of the two interventions: resource-activating behavioural training and intensified exercise training |
| resource-activating training, moderate exercise training | Other | Behavioral: resource-activating behavioural training programme, Behavioral: Moderate aerobic exercise trainingcombination of the two interventions: resource-activating training and moderate exercise training |
| relaxation training, intensified exercise training | Other | Behavioral: Relaxation training, Behavioral: Intensified anaerobic exercise trainingcombination of the two interventions: relaxation training and intensified exercise training |
| relaxation training, moderate exercise training | Other | Behavioral: Relaxation training, Behavioral: Moderate aerobic exercise trainingcombination of the two interventions: relaxation training and moderate exercise training |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals following lung or combined heart-lung transplantation at Hanover Medical School
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resource-activating behavioural training programmeStepwise 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. | Behavioural | resource-activating training, intensified exercise training, resource-activating training, moderate exercise training |
| Relaxation trainingPhase 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. | Behavioural | relaxation training, intensified exercise training, relaxation training, moderate exercise training |
| Intensified anaerobic exercise trainingPhase 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. | Behavioural | relaxation training, intensified exercise training, resource-activating training, intensified exercise training |
| Moderate aerobic exercise trainingPhase 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. | Behavioural | relaxation training, moderate exercise training, resource-activating training, moderate exercise training |
Primary outcome
SF-36 Physical and Psychological Component Summary
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Maximum exercise capacity in Watts absolutely and in percentage predicted and anaerobic threshold
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Oxygen uptake per minute and kg body mass [VO2/min/kg/Body weight] absolutely and in percentage predicted
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Duration of exercise in minutes during constant load tests in the range of the anaerobic threshold
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
6 secondary outcomes
St. George Respiratory Questionnaire (SGRQ)
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Social Support Questionnaire (F-SozU)
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Life Orientation Test (LOT)
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Compliance to medical treatment, exercise training, and lung function measurements at patients' home by an asthma monitor
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
other variables of functional status
Time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
- Background: PubMed 15332404Ambrosino N, Strambi S. New strategies to improve exercise tolerance in chronic obstructive pulmonary disease. Eur Respir J. 2004 Aug;24(2):313-22. doi: 10.1183/09031936.04.00002904.
- Background: PubMed 16822110Blumenthal 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. doi: 10.1037/0022-006X.74.3.535.
- Background: PubMed 15246175De 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. doi: 10.1016/j.socscimed.2004.01.013.
- Background: PubMed 16160585Dew MA, DiMartini AF. Psychological disorders and distress after adult cardiothoracic transplantation. J Cardiovasc Nurs. 2005 Sep-Oct;20(5 Suppl):S51-66. doi: 10.1097/00005082-200509001-00007.
- Background: PubMed 15366436Dew 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. doi: 10.1016/j.healun.2003.07.002.
- Background: PubMed 11496019Dew 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. doi: 10.1176/appi.psy.42.4.300.
- Background: PubMed 10638884Gimenez 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. doi: 10.1016/s0003-9993(00)90229-6.
- Background: PubMed 11951158Hentschel 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. doi: 10.1055/s-2002-25073. German.
- Background: PubMed 16364880Kugler 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. doi: 10.1016/j.healun.2005.07.005. Epub 2005 Nov 17.
- Background: PubMed 10893368Lanuza 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. doi: 10.1378/chest.118.1.115.
- Background: PubMed 17984133Linden W, Phillips MJ, Leclerc J. Psychological treatment of cardiac patients: a meta-analysis. Eur Heart J. 2007 Dec;28(24):2972-84. doi: 10.1093/eurheartj/ehm504. Epub 2007 Nov 5.
- Background: PubMed 15563258Mathur S, Reid WD, Levy RD. Exercise limitation in recipients of lung transplants. Phys Ther. 2004 Dec;84(12):1178-87. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Gündel, Prof. Dr. principal investigator
Dept. of Psychosomatics and Psychotherapy, Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resource-activating behavioural training programme, Relaxation training and Intensified anaerobic exercise training in people with Lung Transplantation and Heart-Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janina Bronisch-Holtze, Dipl.-Psych. (0049-511-532-3133, bronisch-holtze.janina@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Physical and Psychological Component Summary (time frame: T0: before rehab, T1: after rehab, T2: after intervention phase, T3: after 1-year follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808600, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.