Feasibility, Safety and Effectivity of an Exercise Intervention for Newly Diagnosed Multiple Myeloma Patients During Induction Therapy

N/AActive Not RecruitingNCT07026799

University Hospital Heidelberg50 enrolled

Overview

Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone stability. This applies in particular to patients with multiple myeloma, a disease characterized by a monoclonal proliferation of plasma cells in the bone marrow and often accompanied by severe bony destruction. Aim of this exploratory randomized controlled trial is to evaluate feasibility, safety and effectivity of an orthopaedic-guided exercise intervention during induction therapy in newly diagnosed multiple myeloma patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Multiple Myeloma Bone Lesions

Interventions

Orthopedic consultation and home-based, individualized, structured resistance training during induction therapy.

Control groupOTHER

Orthopedic consultation and stretching exercises/walking. No resistance training.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * newly diagnosed multiple myeloma * Survival prognosis \> 6 months * ECOG status ≤ 3 * Age ≥18 years * Patients who state that they want to carry out the training program at least 2 x/week and participate in the planned follow-up visits * Ability to give informed consent * Written consent to participate in the study * Sufficient knowledge of written and spoken German Exclusion Criteria: * physical or mental limitation that would prevent participation in the training program or the planned follow-up visits. * Carrying out a regular, intensive training program (min. 1h, 2x/week)

Locations (1)

Heidelberg University Hospital - GMMG Study Group

Heidelberg, Germany

Outcomes

Primary Outcomes

Fatigue (MFI, Multidimensional Fatigue Inventory)

Time frame: From enrollment to the end of stem cell transplantation (approximately one year)

Data from ClinicalTrials.gov

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