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Acute LeukemiaPACE-ALNCT01404520

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

A study testing Exercise based multimodal intervention in people with Acute Leukemia, run by Universitetshospitalernes Center for Sygepleje at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Leukemia
What is being tested?
Exercise based multimodal intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesDenmark
Study dates
Jun 2011to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Copenhagen University Hospital Rigshospital

    Copenhagen, DK 2100

  • Herlev Hospital

    Herlev, DK 2730

Other trials in Denmark

About this study

Official title: 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.

Conditions
Acute Leukemia
Being tested
Exercise based multimodal intervention
Keywords
#14 Cancer Related fatigue, #13 Quality of Life, #12 "Psychosocial Intervention"[ti/ab], #11 Rehabilitation[tw], #10 "Physical Fitness"[tw], #9 "Physical Activity"[tw], #8 "Exercise Therapy"[tw], #7 Exercise[tw], #6 Hematologic[tw], #5 Hematological[tw], #4 Leukemia, Myeloid, Acute[mh], #3 "Acute Myeloid Leukemia"[tw], #2 "Acute Lymphoblastic Leukemia"[tw], #1 "Acute Leukemia"[tw]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise based multimodal interventionOther

    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.

Study groups in NCT01404520
Study groupRoleWhat they receive
Exercise based multimodal interventionExperimentalThe 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
Receives: Other: Exercise based multimodal intervention
Control GroupNo interventionControl group receives usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six Minute Walk Distance 6MWD

    Change in distance in meter

    Measured: Change from baseline in 6MWD at 12 weeks

Secondary outcomes (8)

  1. Estimated VO2 max Aastrand test

    Change in l/m

    Measured: Change from baseline in VO2 Aastrand test at 12 weeks

  2. Timed chair stand

    Change in number of repetitions

    Measured: Change from baseline in timed chair stand at 12 weeks

  3. Timed biceps curl

    Change in number of repetitions

    Measured: Change from baseline in timed bicep curl at 12 weeks

  4. EORTC QLQ-C30

    Change in scores for quality of life

    Measured: Change from baseline in EORTC QLQ-C30 at 12 weeks

  5. FACT-An

    Change in scores for quality of life/function

    Measured: Change from baseline in FACT-An at 12 weeks

  6. HADS

    Change in scores for emotional wellbeing

    Measured: Change from baseline in HADS at 12 weeks

  7. SF36

    Change in scores for general health

    Measured: Change from baseline in SF36 at 12 weeks

  8. MDASI

    Change in scores for symptom burden

    Measured: Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionMay 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01404520
Sponsor's protocol ID
H-4-2010-046
Acronym
PACE-AL
Status last verified
Nov 2015
First submitted
10 May 2011
Last updated
2 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Jarden M, Moller T, Christensen KB, Kjeldsen L, Birgens HS, Adamsen L. Multimodal intervention integrated into the clinical management of acute leukemia improves physical function and quality of life during consolidation chemotherapy: a randomized trial 'PACE-AL'. Haematologica. 2016 Jul;101(7):e316-9. doi: 10.3324/haematol.2015.140152. Epub 2016 Apr 1. No abstract available.

    PubMed 27036163

  • Jarden M, Moller T, Kjeldsen L, Birgens H, Christensen JF, Bang Christensen K, Diderichsen F, Hendriksen C, Adamsen L. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial. BMC Cancer. 2013 Oct 2;13:446. doi: 10.1186/1471-2407-13-446.

    PubMed 24083543

Questions about this trial

What is this clinical trial studying?

A study testing Exercise based multimodal intervention in people with Acute Leukemia, run by Universitetshospitalernes Center for Sygepleje at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Minute Walk Distance 6MWD (time frame: Change from baseline in 6MWD at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01404520, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.

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