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

November 30, 2015 updated by: Mary Jarden, Universitetshospitalernes Center for Sygepleje

Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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, DK 2100
        • Copenhagen University Hospital Rigshospital
      • Herlev, Denmark, DK 2730
        • 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 cardial disease
  • Documented bone metastasis
  • Cognitively or emotionally unstable
  • Unable to read or write in 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise based multimodal intervention
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
Other: Exercise based multimodal intervention
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.
No Intervention: Control Group
Control group receives usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk Distance 6MWD
Time Frame: Change from baseline in 6MWD at 12 weeks
Change in distance in meter
Change from baseline in 6MWD at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated VO2 max Aastrand test
Time Frame: Change from baseline in VO2 Aastrand test at 12 weeks
Change in l/m
Change from baseline in VO2 Aastrand test at 12 weeks
Timed chair stand
Time Frame: Change from baseline in timed chair stand at 12 weeks
Change in number of repetitions
Change from baseline in timed chair stand at 12 weeks
Timed biceps curl
Time Frame: Change from baseline in timed bicep curl at 12 weeks
Change in number of repetitions
Change from baseline in timed bicep curl at 12 weeks
EORTC QLQ-C30
Time Frame: Change from baseline in EORTC QLQ-C30 at 12 weeks
Change in scores for quality of life
Change from baseline in EORTC QLQ-C30 at 12 weeks
FACT-An
Time Frame: Change from baseline in FACT-An at 12 weeks
Change in scores for quality of life/function
Change from baseline in FACT-An at 12 weeks
HADS
Time Frame: Change from baseline in HADS at 12 weeks
Change in scores for emotional wellbeing
Change from baseline in HADS at 12 weeks
SF36
Time Frame: Change from baseline in SF36 at 12 weeks
Change in scores for general health
Change from baseline in SF36 at 12 weeks
MDASI
Time Frame: Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)
Change in scores for symptom burden
Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 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
University of Copenhagen
Danish Cancer Society
Lundbeck Foundation

Investigators

  • Principal Investigator: Mary Jarden, Ph.D., UCSF and CIRE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2010-046

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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