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

Not Applicable

Completed

• Conditions: Acute Leukemia
• Interventions: Other: Exercise based multimodal intervention

• Registration Number: NCT01404520
• Lead Sponsor: Universitetshospitalernes Center for Sygepleje

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-10
• Study Start: 2011-06
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2014-05
• Study Completion: 2015-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise based multimodal intervention	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

Primary Outcome Measures

Name	Time	Method
Six Minute Walk Distance 6MWD	Change from baseline in 6MWD at 12 weeks	Change in distance in meter

Secondary Outcome Measures

Name	Time	Method
Estimated VO2 max Aastrand test	Change from baseline in VO2 Aastrand test at 12 weeks	Change in l/m
Timed chair stand	Change from baseline in timed chair stand at 12 weeks	Change in number of repetitions
Timed biceps curl	Change from baseline in timed bicep curl at 12 weeks	Change in number of repetitions
EORTC QLQ-C30	Change from baseline in EORTC QLQ-C30 at 12 weeks	Change in scores for quality of life
FACT-An	Change from baseline in FACT-An at 12 weeks	Change in scores for quality of life/function
HADS	Change from baseline in HADS at 12 weeks	Change in scores for emotional wellbeing
SF36	Change from baseline in SF36 at 12 weeks	Change in scores for general health
MDASI	Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)	Change in scores for symptom burden

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Copenhagen University Hospital Rigshospital; 🇩🇰 Copenhagen, Denmark