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Clinical Trials/NCT00427115
NCT00427115
Completed
Phase 3

Pilot Study of an Exercise an Psycho-Educational Intervention During Allogeneic Stem Cell Transplantation

Rigshospitalet, Denmark1 site in 1 country42 target enrollmentAugust 2005
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ConditionsAllogeneic Stem Cell TransplantationLeukemia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Allogeneic Stem Cell Transplantation
Sponsor
Rigshospitalet, Denmark
Enrollment
42
Locations
1
Primary Endpoint
Physical capacity VO2 max, muscle strength (1RM, Isometric), stair test
Status
Completed
Last Updated
17 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2005
End Date
April 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Outcomes

Primary Outcomes

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

Time Frame: Baseline, post

Secondary Outcomes

  • 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)

Study Sites (1)

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