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Exercise in Patients With Multiple Myeloma (EMMY)

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ClinicalTrials.gov Identifier: NCT02439112
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Odense University Hospital
Region Zealand
Region of Southern Denmark
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

The overall aim is to examine whether early initiated, individualized exercise training in patients newly diagnosed with multiple myeloma, irrespective of age and current performance status, will be beneficial for the patients´physical function, level of physical activity and quality of life, pain and bone disease.

The investigators will examine the effect of supervised in-hospital exercise training sessions combined with home-based exercise training, initiated at time of diagnosis. The outcomes of interest are physical function, level of physical activity, QOL, pain and bone disease.

Furthermore, to describe the disease in patients with newly diagnosed MM in relation to physical function, level of physical activity, QOL, pain and bone condition at time of diagnosis.

The investigators hypotheses are:

  • Individualized exercise starting at time of diagnosis will have positive effects on physical function, physical activity, QOL and pain.
  • Individualized exercise starting at time of diagnosis will have positive effects on bone disease (bone markers), bone mineral density (BMD) and lean body mass.
  • A higher level of physical function is associated with a higher level of physical activity, less pain, better QOL, and higher BMD and lean body mass.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Early Initiated Individualized Physical Training in Newly Diagnosed Multiple Myeloma Patients; Effects on Physical Function, Physical Activity, Quality of Life, Pain, and Bone Disease.
Study Start Date : May 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active Comparator: Exercise
Supervised exercise combined with home based exercise and physical activity
Other: Exercise

8 supervised in-hospital training sessions in a period of 10 weeks. On a general level, the intervention will follow the Danish physical activity guidelines for elderly >65 years (Sundhedsstyrelsen 2011, see link) and consist of strength exercise, aerobic exercise and physical activity.

Bone involvement will taken into consideration in all parts of the exercise program by excluding and including specific exercises and mode of exercise according to location and extent of bone involvement (Galvão 2011; Cormie 2013)


No Intervention: Control
Usual care consisting of advice regarding exercise, physical activity, person lifting and moving.



Primary Outcome Measures :
  1. Change in isometric knee extension strength measured by handhold dynamometer [ Time Frame: From baseline to follow-up after 11 weeks ]

Secondary Outcome Measures :
  1. Change in isometric knee extension strength measured by handhold dynamometer [ Time Frame: Baseline and follow-up after 6 months and 12 months ]
  2. Change in lower limb strength measured by Sit-to-Stand Test [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    Functional test of lower limb strength

  3. Change in grip strength measured by hand dynamometer [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
  4. Change in aerobic capacity measured by 6 Minutes Walk Test [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    Test of submaximal aerobic capacity

  5. Change in Quality of Life assessed by self-reported questionnaire [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20) (68)

  6. Change in pain assessed by self-reported questionnaire [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    Brief Pain Inventory (BPI) (70,71)

  7. Change in level of physical activity measured by accelerometer [ Time Frame: Baseline and follow-up after, 4 weeks, 7 weeks, 11 weeks, 6 months and 12 months ]
    Measured objectively by accelerometer (ActivPal) in periods of 5 days

  8. Change in bone disease - dynamic markers [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    Osteoblast and osteoclast activity measured by dynamic markers (PINP and CTX-1) of bone metabolism in serum.

  9. Change in bone disease - Bone Mineral Density assessed by DEXA scans [ Time Frame: Baseline and follow-up after 6 months and 12 months ]
    Dual-Energy X-ray Absorptiometry (DEXA)

  10. Change in Lean Body Mass assessed by DEXA scans [ Time Frame: Baseline and follow-up after 11 weeks, 6 months and 12 months ]
    Dual-Energy X-ray Absorptiometry (DEXA)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed with Multiple Myeloma requiring treatment.
  • The patient must be able to speak and understand Danish and be able to give his/her informed consent.

Exclusion Criteria:

  • Patients with spinal cord compression
  • Unstable vertebral fracture (SINS score >12) (52)
  • Untreated cardiac failure and untreated cardiac arrythmia
  • Severe chronic cardiac failure (NYHA 3-4)
  • Other severe comorbidity that will not allow physical training, e.g. neurological or uncompensated liver failure and psychological or psychiatric disorder that will not allow compliance in physical training.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439112


Contacts
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Contact: Rikke F Larsen, Ph.d.student +45 47324752 rfl@regionsjaelland.dk
Contact: Niels Abildgaard, Professor +45 23221584 ext +45 65411155 Niels.Abildgaard@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Rikke Faebo Larsen, Master of Health Science    +45 47324752    rfl@regionsjaelland.dk   
Contact: Niels Abildgaard, Professor    +45 65411155    niels.abildgaard@rsyd.dk   
Zealand University Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Rikke Faebo Larsen, Master of Health Science    +45 47324752    rfl@regionsjaelland.dk   
Contact: Niels Abildgaard, Professor    +45 65411155    niels.abildgaard@rsyd.dk   
Sponsors and Collaborators
Zealand University Hospital
Odense University Hospital
Region Zealand
Region of Southern Denmark
Association of Danish Physiotherapists
Investigators
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Principal Investigator: Rikke F Larsen, Ph.d.student Department of Rheumatologic, Roskilde and Koege Hospital, DK
Study Chair: Niels Abildgaard, Professor Department of Hematology, Odense University Hospital, DK and professor at University of Southern Denmark

Publications:

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02439112     History of Changes
Other Study ID Numbers: Reum,fys/ergo 1
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zealand University Hospital:
Exercise
Physical Function
Physical Activity
Quality of Life
Pain
Bone Disease

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Musculoskeletal Diseases