Multimodal Intervention in Allogeneic Stem Cell Transplantation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427115

Enrollment

Registered

2007-01-26

Start date

2005-08-31

Completion date

2008-04-30

Last updated

2008-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allogeneic Stem Cell Transplantation, Leukemia

Keywords

Patients undergoing allogeneic stem cell transplantations

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.

Interventions

BEHAVIORALMultimodal exercise and psychosocial program

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026