NCT00427115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

Enrollment Period

2.3 years

First QC Date

January 25, 2007

Last Update Submit

May 20, 2008

Conditions

Allogeneic Stem Cell TransplantationLeukemia

Keywords

Patients undergoing allogeneic stem cell transplantations

Outcome Measures

Primary Outcomes (1)

  • Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test

    Baseline, post

Secondary Outcomes (2)

  • 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

Interventions

Multimodal exercise and psychosocial programBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs
  • patients undergoing allogeneic stem cell transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mary E Jarden, MSN PhD stud

    Copenhagen University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Lis Adamsen, ProfessorPhD

    Copehagen University, Faculty of Health Sciences, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 26, 2007

Study Start

August 1, 2005

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

DK(1)