Exercise in Patients With Multiple Myeloma
NCT02439112 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2020-12-17
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
Interventions
- 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)
Sponsors & Collaborators
-
Odense University Hospital
collaborator OTHER -
Region Zealand
collaborator OTHER -
Region of Southern Denmark
collaborator OTHER -
Association of Danish Physiotherapists
collaborator OTHER -
Zealand University Hospital
lead OTHER
Principal Investigators
-
Rikke F Larsen, Ph.d. · Department of Hematology, Odense University Hospital, DK
-
Niels Abildgaard, Professor · Department of Hematology, Odense University Hospital, DK and University of Southern Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2020-02-05
- Completion
- 2020-12-01
Countries
- Denmark
Study Locations
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