Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

Early Phase 1CompletedNCT01557686

Universitetshospitalernes Center for Sygepleje20 enrolled

Overview

The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Leukemia

Interventions

Health counseling and exerciseBEHAVIORAL

The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 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 two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.

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 cardiac disease within the last three months. * Documented bone metastasis * Dementia, psychotic * Cannot write or read Danish * Patients unable to carry out baseline tests

Locations (2)

Copenhagen University Hospital

Copenhagen, Denmark

Herlev Hospital

Herlev, Denmark

Outcomes

Primary Outcomes

Feasibility - adherence rates

Percentage of intervention participation

Time frame: Adherence to the intervention components from baseline to 6 weeks

Secondary Outcomes

Adverse events

Number and type of adverse events

Time frame: baseline to 6 weeks

6MWD

Change in distance in meter

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

Attrition

Number of patients that withdrew from the project

Time frame: Withdrawal from the project from baseline to 6 weeks

Timed chair stand

Change in the number of repetitions

Time frame: Change from baseline in timed chair stand at 6 weeks

Timed bicep curl

Change in number of repetitions

Time frame: Change from baseline in timed bicep curl at 6 weeks

FACT-Anemia

Change in scores for quality of life/function

Time frame: Change from baseline in FACT-An at 6 weeks

HADS

Change in scores for emotional wellbeing

Time frame: Change from baseline in HADS at 6 weeks

SF36

Change in scores for general health

Data from ClinicalTrials.gov

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