Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study (PACE-AL)

March 16, 2012 updated by: Mary Jarden, Universitetshospitalernes Center for Sygepleje

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital
      • Herlev, Denmark
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitetshospitalernes Center for Sygepleje

Collaborators

Novo Nordisk A/S
Lundbeck Foundation

Investigators

  • Principal Investigator: Mary Jarden, Ph.D., Copenhagen University Hospital at Herlev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2010-046 Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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