Effects of a Resistance Physical Exercise Program in Multiple Myeloma Patients
"Effects of a Resistance Physical Exercise Program in Multiple Myeloma Patients: A Randomized Controlled Trial Study Protocol".
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The goal of this clinical trial is to learn if physical exercise improves quality of life, frailty and mental health in patients with multiple myeloma. It will also learn about the safety and adherence of the program. The main questions it aims to answer are: Does physical exercise improves quality of life in patients with multiple myeloma? Does physical exercise improves frailty and mental health in patients with multiple myeloma? Researchers will compare supervised physical exercise and home-based unsupervised physical exercise. Participants will: Participate in one of the exercise programs, supervised or home-based, for 12 weeks. They will be completely evaluated before and after the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedNovember 28, 2025
November 1, 2025
3 months
November 16, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health related quality of life
The primary outcome measure will be health related quality of life. Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Specifically, the EORTC QLQ-C30 will be used, which is widely used to assess quality of life in cancer patients \[X\]. This instrument consists of 30 items, 24 of which are grouped into five functional domains: physical, role, emotional, cognitive, and social. It also includes three symptom scales-fatigue, pain, and nausea/vomiting-and an overall health status scale. Six other items assess additional symptoms such as dyspnoea, loss of appetite, insomnia, constipation, diarrhoea, and financial difficulties. Responses are recorded on a four-point scale ('none,' 'a little,' 'quite a bit,' 'a lot'), except for the general health and quality of life scales, which use a seven-point format. On the functional and overall health scales, higher scores indicate better health, while on the
12 weeks
Secondary Outcomes (8)
Frailty
12 weeks
Anxiety and depression
12 weeks
Fatigue
12 weeks
Sleep quality
12 weeks
Physical activity
12 weeks
- +3 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALSupervised physical exercise program
Control group
EXPERIMENTALHome-based physical exercise program
Interventions
Participants will follow a supervised physical exercise program for 12 weeks.
Participants will follow a home-based physical exercise program for 12 weeks.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of MM undergoing active treatment.
- No regular physical activity during the previous eight weeks.
- Functional status (ECOG) 0-1.
- Signature of informed consent.
You may not qualify if:
- Presence of medical contraindications for physical exercise, such as severe musculoskeletal disorders, severe cardiovascular disease, bone metastases, or other conditions that the medical team considers inappropriate.
- Inability to complete the initial assessment tests or difficulty performing basic exercises.
- Any other circumstance that, in the opinion of the investigators, may interfere with the objectives or conduct of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Fairman CM, Zourdos MC, Helms ER, Focht BC. A Scientific Rationale to Improve Resistance Training Prescription in Exercise Oncology. Sports Med. 2017 Aug;47(8):1457-1465. doi: 10.1007/s40279-017-0673-7.
PMID: 28074412BACKGROUNDKirkham AA, Eves ND, Shave RE, Bland KA, Bovard J, Gelmon KA, Virani SA, McKenzie DC, Stohr EJ, Waburton DER, Campbell KL. The effect of an aerobic exercise bout 24 h prior to each doxorubicin treatment for breast cancer on markers of cardiotoxicity and treatment symptoms: a RCT. Breast Cancer Res Treat. 2018 Feb;167(3):719-729. doi: 10.1007/s10549-017-4554-4. Epub 2017 Nov 6.
PMID: 29110150BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Given the study design, it will not be possible to blind participants or assessors to the intervention. However, in order to preserve the objectivity of the results, the statistical analysis will be performed by an independent statistician who is not involved in the study and is unaware of the allocation of participants to the different groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 16, 2025
First Posted
November 28, 2025
Study Start
February 1, 2026
Primary Completion
May 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
November 28, 2025
Record last verified: 2025-11