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

Universitetshospitalernes Center for Sygepleje70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Acute Leukemia

Interventions

Exercise based multimodal interventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Copenhagen University Hospital Rigshospital

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Six Minute Walk Distance 6MWD

Change in distance in meter

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

Secondary Outcomes

Estimated VO2 max Aastrand test

Change in l/m

Time frame: Change from baseline in VO2 Aastrand test at 12 weeks

Timed chair stand

Change in number of repetitions

Time frame: Change from baseline in timed chair stand at 12 weeks

Timed biceps curl

Change in number of repetitions

Time frame: Change from baseline in timed bicep curl at 12 weeks

EORTC QLQ-C30

Change in scores for quality of life

Time frame: Change from baseline in EORTC QLQ-C30 at 12 weeks

FACT-An

Change in scores for quality of life/function

Time frame: Change from baseline in FACT-An at 12 weeks

HADS

Change in scores for emotional wellbeing

Time frame: Change from baseline in HADS at 12 weeks

SF36

Change in scores for general health

Time frame: Change from baseline in SF36 at 12 weeks

MDASI

Change in scores for symptom burden

Data from ClinicalTrials.gov

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