Multimodal Intervention in Allogeneic Stem Cell Transplantation

Phase 3

Completed

• Conditions: Allogeneic Stem Cell Transplantation; Leukemia

• Registration Number: NCT00427115
• Lead Sponsor: Rigshospitalet, Denmark

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 available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-26
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-20
• Last Update Posted: 2008-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test	Baseline, post

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark