Back to resultsHealth Counseling and Exercise in Patients With Acute Leukemia - Pilot Study (PACE-AL)
Primary Purpose
Acute Leukemia
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Health counseling and exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Leukemia focused on measuring 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
Eligibility Criteria
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
Sites / Locations
- Copenhagen University Hospital
- Herlev Hospital
Outcomes
Primary Outcome Measures
Feasibility - adherence rates
Percentage of intervention participation
Secondary Outcome Measures
Adverse events
Number and type of adverse events
6MWD
Change in distance in meter
Attrition
Number of patients that withdrew from the project
Timed chair stand
Change in the number of repetitions
Timed bicep curl
Change in number of repetitions
FACT-Anemia
Change in scores for quality of life/function
HADS
Change in scores for emotional wellbeing
SF36
Change in scores for general health
MDSAI
Change in scores for symptom burden
Full Information
NCT ID
NCT01557686
First Posted
March 15, 2012
Last Updated
March 16, 2012
Sponsor
Universitetshospitalernes Center for Sygepleje
Collaborators
Novo Nordisk A/S, Lundbeck Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01557686
Brief Title
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
Acronym
PACE-AL
Official Title
Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitetshospitalernes Center for Sygepleje
Collaborators
Novo Nordisk A/S, Lundbeck Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Health counseling and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - adherence rates
Description
Percentage of intervention participation
Time Frame
Adherence to the intervention components from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number and type of adverse events
Time Frame
baseline to 6 weeks
Title
6MWD
Description
Change in distance in meter
Time Frame
Change from baseline in 6MWD at 6 weeks
Title
Attrition
Description
Number of patients that withdrew from the project
Time Frame
Withdrawal from the project from baseline to 6 weeks
Title
Timed chair stand
Description
Change in the number of repetitions
Time Frame
Change from baseline in timed chair stand at 6 weeks
Title
Timed bicep curl
Description
Change in number of repetitions
Time Frame
Change from baseline in timed bicep curl at 6 weeks
Title
FACT-Anemia
Description
Change in scores for quality of life/function
Time Frame
Change from baseline in FACT-An at 6 weeks
Title
HADS
Description
Change in scores for emotional wellbeing
Time Frame
Change from baseline in HADS at 6 weeks
Title
SF36
Description
Change in scores for general health
Time Frame
Change from baseline in SF36 at 6 weeks
Title
MDSAI
Description
Change in scores for symptom burden
Time Frame
Change from baseline over time (1,2,3,4,5,6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jarden, Ph.D.
Organizational Affiliation
Copenhagen University Hospital at Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study
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