Exercise CapacityErgo-HTxNCT00752336
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
A study testing exercise training; psychosocial support in people with Exercise Capacity and Heart Transplantation, run by Hannover Medical School.
Trial summary
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity, Heart Transplantation
- What is being tested?
- exercise training; psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Sep 2009
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)
- Age ≥ 18 yrs
- Sufficient language skills to answer questionnaire
- Follow-up at our center
- Willingness to participate by written informed consent
Who cannot join
- TVP diagnosis before study inclusion
- Episodes of recurrent acute rejections
- Medical contra-indication for regular exercise ergometer training
- Malignancy
About this study
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.
- Conditions
- Exercise Capacity, Heart Transplantation
- Being tested
- exercise training; psychosocial support
- Keywords
- HRQoL, exercise capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training; psychosocial supportBehavioural
supervised home-based endurance training; recommendation to exercise every other day
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL,exercise capacity
Measured: 36 mts
Secondary outcomes (1)
Weight gain; cardiovascular risk factors; social re-integration
Measured: 36 mts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startJan 2002
- Primary completionSep 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752336
- Sponsor's protocol ID
- HTx-2777
- Acronym
- Ergo-HTx
- Status last verified
- Sep 2008
- First submitted
- 12 Sep 2008
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
- ClinicalTrials.gov ID
- NCT00752336
- Acronym / sponsor ID
- Ergo-HTx / HTx-2777
- Conditions
- Exercise Capacity, Heart Transplantation
- Keywords
- HRQoL, exercise capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2002
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 15 Sep 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.
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)
- Age ≥ 18 yrs
- Sufficient language skills to answer questionnaire
- Follow-up at our center
- Willingness to participate by written informed consent
Key exclusion criteria (4 listed)
- TVP diagnosis before study inclusion
- Episodes of recurrent acute rejections
- Medical contra-indication for regular exercise ergometer training
- Malignancy
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 |
|---|---|---|
| exercise training; psychosocial supportsupervised home-based endurance training; recommendation to exercise every other day | Behavioural | – |
Primary outcome
HRQoL,exercise capacity
Time frame: 36 mts
1 secondary outcome
Weight gain; cardiovascular risk factors; social re-integration
Time frame: 36 mts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training; psychosocial support in people with Exercise Capacity and Heart Transplantation, run by Hannover Medical School.
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 5 inclusion and 4 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 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL,exercise capacity (time frame: 36 mts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2008.