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

Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01557686

Acronym

PACE-AL

Enrollment

Registered

2012-03-19

Start date

2010-05-31

Completion date

2011-02-28

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Keywords

Cancer Related fatigue, Quality of Life, Psychosocial Intervention, Rehabilitation, Physical Fitness, Physical Activity, Exercise Therapy, Exercise, Hematologic, Hematological, Leukemia, Myeloid, Acute, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Leukemia

Brief summary

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.

Interventions

BEHAVIORALHealth counseling and exercise

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility - adherence rates	Adherence to the intervention components from baseline to 6 weeks	Percentage of intervention participation

Secondary

Measure	Time frame	Description
HADS	Change from baseline in HADS at 6 weeks	Change in scores for emotional wellbeing
SF36	Change from baseline in SF36 at 6 weeks	Change in scores for general health
MDSAI	Change from baseline over time (1,2,3,4,5,6 weeks)	Change in scores for symptom burden
Attrition	Withdrawal from the project from baseline to 6 weeks	Number of patients that withdrew from the project
6MWD	Change from baseline in 6MWD at 6 weeks	Change in distance in meter
Timed bicep curl	Change from baseline in timed bicep curl at 6 weeks	Change in number of repetitions
FACT-Anemia	Change from baseline in FACT-An at 6 weeks	Change in scores for quality of life/function
Adverse events	baseline to 6 weeks	Number and type of adverse events
Timed chair stand	Change from baseline in timed chair stand at 6 weeks	Change in the number of repetitions

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026