Exercise in Patients With Multiple Myeloma

NCT02439112 | Completed DMC

• 1 other identifier: Reum,fys/ergo 1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Exercise; Physical Function; Physical Activity; Quality of Life; Pain; Bone Disease

Outcome Measures

Primary Outcomes (1)

• Change in isometric knee extension strength measured by handhold dynamometer

  kilogram and newton

  From baseline to follow-up after 11 weeks

Secondary Outcomes (10)

• Change in isometric knee extension strength measured by handhold dynamometer

  Baseline and follow-up after 6 months and 12 months

• Change in lower limb strength measured by Sit-to-Stand Test

  Baseline and follow-up after 11 weeks, 6 months and 12 months

• Change in grip strength measured by hand dynamometer

  Baseline and follow-up after 11 weeks, 6 months and 12 months

• Change in aerobic capacity measured by 6 Minutes Walk Test

  Baseline and follow-up after 11 weeks, 6 months and 12 months

• Change in Quality of Life assessed by self-reported questionnaire

  Baseline and follow-up after 11 weeks, 6 months and 12 months

Study Arms (2)

Exercise

ACTIVE COMPARATOR

Supervised exercise combined with home based exercise and physical activity

Other: Exercise

Control

NO INTERVENTION

Usual care consisting of advice regarding exercise, physical activity, person lifting and moving.

Interventions

Exercise OTHER

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)

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Odense University Hospital: collaborator
• Region Zealand: collaborator
• Region of Southern Denmark: collaborator
• Association of Danish Physiotherapists: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (42)

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• Larsen RF, Jarden M, Minet LR, Frolund UC, Moller S, Abildgaard N. Physical function in patients newly diagnosed with multiple myeloma; a Danish cohort study. BMC Cancer. 2020 Mar 3;20(1):169. doi: 10.1186/s12885-020-6637-6.

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• Larsen RF, Jarden M, Minet LR, Frolund UC, Abildgaard N. Supervised and home-based physical exercise in patients newly diagnosed with multiple myeloma-a randomized controlled feasibility study. Pilot Feasibility Stud. 2019 Nov 12;5:130. doi: 10.1186/s40814-019-0518-2. eCollection 2019.

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MeSH Terms

Conditions

Multiple Myeloma; Motor Activity; Pain; Bone Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rikke F Larsen, Ph.d.

  Department of Hematology, Odense University Hospital, DK

  PRINCIPAL INVESTIGATOR

• Niels Abildgaard, Professor

  Department of Hematology, Odense University Hospital, DK and University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 8, 2015
• Study Start: May 1, 2015
• Primary Completion: February 5, 2020
• Study Completion: December 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)