Effects of a Resistance Physical Exercise Program in Multiple Myeloma Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Supervised physical exercise

    Other intervention

    Participants will follow a supervised physical exercise program for 12 weeks.

  • Home-based physical exercise program

    Other intervention

    Participants will follow a home-based physical exercise program for 12 weeks.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 2 interventions
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

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

Time frame
12 weeks

Secondary outcomes

1

Frailty

Frailty will be assessed using the Short Physical Performance Battery (SPPB) scale \[X\], which comprises three components: a balance test, a gait speed test, and a chair rise test. The maximum possible score is 12 points, with higher scores reflecting a better level of physical function.

Time frame
12 weeks
2

Anxiety and depression

The presence of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), a validated questionnaire widely used in different populations \[X\]. The scale consists of 14 items: seven corresponding to the anxiety subscale (HADS-A) and seven to the depression subscale (HADS-D). Each item is scored from 0 to 3, with separate scores obtained for both emotional dimensions.

Time frame
12 weeks
3

Fatigue

Fatigue will be measured using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale \[X\], a self-reported instrument designed to assess the severity of fatigue in cancer patients \[X,X\]. This widely used tool combines the 27 items of the FACT-General with 13 additional fatigue-specific items, generating a total score range between 0 and 160. Higher scores indicate lower perceived fatigue levels.

Time frame
12 weeks
4

Sleep quality

Sleep quality will be assessed using the Athens Insomnia Scale (AIS), an eight-item self-administered scale developed by Soldatos \[X\] and validated for use in the Spanish population \[X\]. The first five items assess sleep disturbances-sleep onset, night-time awakenings, early awakening, total sleep duration, and overall quality-corresponding to criterion 'A' for the diagnosis of insomnia according to the ICD-10 classification. The remaining three items assess daytime consequences (well-being, physical and mental functioning, and daytime sleepiness), aligned with criterion 'C' of the same classification. Each item is scored on a Likert scale from 0 ('no problem') to 3 ('significant problem'), yielding a total range of 0 to 24. Higher scores indicate greater sleep disturbance, and values equal to or greater than 6 are considered indicative of clinically relevant insomnia \[X\].

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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