Multimodal Intervention in Allogeneic Stem Cell Transplan... | NCT00427115

Studies
Multimodal Intervention in Allogeneic Stem Cell Transplantation

NCT00427115

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

May 21, 2008Estimated

Enrollment

42Actual

Phase

Phase 3

Conditions

Allogeneic Stem Cell Transplantation
Leukemia

Interventions

Multimodal exercise and psychosocial program

Countries

Denmark

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

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 25, 2007

First Submission Date that Met QC Criteria

Jan 25, 2007

First Posted Date

Jan 26, 2007Estimated

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

May 20, 2008

Last Update Posted Date

May 21, 2008Estimated

Description Module

Brief Summary

Objective: To evaluate the feasibility and safety of a 4-6 weeks exercise - psycho-educational intervention in patients undergoing allogeneic stem cell transplantation (allo-HCST). The intervention included structured and supervised exercise, relaxation and psycho-educational components. It was hypothesized that the intervention would minimize loss of physical capacity during hospitalization.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Name	Type	Description	Arm Group Labels	Other Names
Multimodal exercise and psychosocial program	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test		Baseline, post

Secondary Outcomes

Measure	Description	Time Frame
quality of life indices		baseline, post, 3 and 6 months
FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form		baseline, post, 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 yrs
patients undergoing allogeneic stem cell transplantation

Exclusion Criteria:

recent cardiovascular or pulmonary disease
abnormal EKG
psychiatric disorder
motor function, musculoskeletal or neurological disturbances
bony metastasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary E Jarden, MSN PhD stud	Copenhagen University Hospital, Denmark	Principal Investigator
Lis Adamsen, ProfessorPhD	Copehagen University, Faculty of Health Sciences, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital		Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided