Prospective Intervention Study to Improve HRQoL and Exerc... | NCT00752336

Studies
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation

NCT00752336

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Sep 15, 2008Estimated

Enrollment

87Actual

Phase

Not Applicable

Conditions

Exercise Capacity
Heart Transplantation

Interventions

exercise training; psychosocial support

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Sep 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Sep 12, 2008

First Submission Date that Met QC Criteria

Sep 12, 2008

First Posted Date

Sep 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2008

Last Update Posted Date

Sep 15, 2008Estimated

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
exercise training; psychosocial support	Behavioral	supervised home-based endurance training; recommendation to exercise every other day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HRQoL,exercise capacity		36 mts

Secondary Outcomes

Measure	Description	Time Frame
Weight gain; cardiovascular risk factors; social re-integration		36 mts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

TVP diagnosis before study inclusion
Episodes of recurrent acute rejections
Medical contra-indication for regular exercise ergometer training
Malignancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D000067250	Psychiatric Rehabilitation

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided