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

Universitetshospitalernes Center for Sygepleje

Status: Completed

Conditions: Acute Leukemia

Treatments: Other: Exercise based multimodal intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01404520

H-4-2010-046

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 cardial disease
• Documented bone metastasis
• Cognitively or emotionally unstable
• Unable to read or write in Danish
• Patients unable to carry out baseline tests

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Exercise based multimodal intervention

Experimental group

Description:

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

Treatment:

Other: Exercise based multimodal intervention

Control Group

No Intervention group

Description:

Control group receives usual care