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Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL)

NCT01404520 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-12-02

No results posted yet for this study

Summary

The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.

Conditions

Interventions

OTHER

Exercise based multimodal intervention

The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Danish Cancer Society

    collaborator OTHER

  • Lundbeck Foundation

    collaborator OTHER

  • Universitetshospitalernes Center for Sygepleje

    lead OTHER

Principal Investigators

  • Mary Jarden, Ph.D. · UCSF and CIRE

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-05-31
Completion
2015-05-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404520 on ClinicalTrials.gov