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Completed

NCT Number: NCT00427115

Multimodal Intervention in Allogeneic Stem Cell Transplantation

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.

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Key information

Conditions

Allogeneic Stem Cell Transplantation Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal exercise and psychosocial program

Behavioral

Primary outcomes

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

    Time frame: Baseline, post

Secondary outcomes

  1. quality of life indices

    Time frame: baseline, post, 3 and 6 months

  2. FACT-An, EORTC, HADS, Mini-Mac, Symptom Assessment form

    Time frame: baseline, post, 3 and 6 months

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jan 26, 2007
Registry last updated
May 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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