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

Acute Leukemia Clinical Trial

— PACE-AL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404520
• Other study ID #: H-4-2010-046
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: November 30, 2015
• Start date: June 2011
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: Universitetshospitalernes Center for Sygepleje
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Rigshospital	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (5)

Lead Sponsor	Collaborator
Universitetshospitalernes Center for Sygepleje	Danish Cancer Society, Lundbeck Foundation, Novo Nordisk A/S, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walk Distance 6MWD	Change in distance in meter	Change from baseline in 6MWD at 12 weeks	Yes
Secondary	Estimated VO2 max Aastrand test	Change in l/m	Change from baseline in VO2 Aastrand test at 12 weeks	Yes
Secondary	Timed chair stand	Change in number of repetitions	Change from baseline in timed chair stand at 12 weeks	Yes
Secondary	Timed biceps curl	Change in number of repetitions	Change from baseline in timed bicep curl at 12 weeks	Yes
Secondary	EORTC QLQ-C30	Change in scores for quality of life	Change from baseline in EORTC QLQ-C30 at 12 weeks	No
Secondary	FACT-An	Change in scores for quality of life/function	Change from baseline in FACT-An at 12 weeks	No
Secondary	HADS	Change in scores for emotional wellbeing	Change from baseline in HADS at 12 weeks	No
Secondary	SF36	Change in scores for general health	Change from baseline in SF36 at 12 weeks	No
Secondary	MDASI	Change in scores for symptom burden	Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)	No