Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy

Universitetshospitalernes Center for Sygepleje2 sites in 1 country70 target enrollmentJune 2011

ConditionsAcute Leukemia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Leukemia
Sponsor: Universitetshospitalernes Center for Sygepleje
Enrollment: 70
Locations: 2
Primary Endpoint: Six Minute Walk Distance 6MWD
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universitetshospitalernes Center for Sygepleje

Responsible Party

Principal Investigator

Mary Jarden

Research Fellow

Universitetshospitalernes Center for Sygepleje

Eligibility Criteria

Inclusion Criteria

•Patients that are able to speak Danish \> 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
•Normal EKG, blood pressure and pulse
•Signed informed written consent

Exclusion Criteria

•Medical reason that contraindicates physical activity
•Patients diagnosed with a symptomatic cardial disease
•Documented bone metastasis
•Cognitively or emotionally unstable
•Unable to read or write in Danish
•Patients unable to carry out baseline tests

Outcomes

Primary Outcomes

Six Minute Walk Distance 6MWD

Time Frame: Change from baseline in 6MWD at 12 weeks

Change in distance in meter

Secondary Outcomes

Estimated VO2 max Aastrand test(Change from baseline in VO2 Aastrand test at 12 weeks)
Timed chair stand(Change from baseline in timed chair stand at 12 weeks)
Timed biceps curl(Change from baseline in timed bicep curl at 12 weeks)
EORTC QLQ-C30(Change from baseline in EORTC QLQ-C30 at 12 weeks)
FACT-An(Change from baseline in FACT-An at 12 weeks)
HADS(Change from baseline in HADS at 12 weeks)
SF36(Change from baseline in SF36 at 12 weeks)
MDASI(Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks))