Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients

Not Applicable

Recruiting

• Conditions: Multiple Myeloma; Balance Training Effects; Fall Risk Factors; Strength Training Effects

• Registration Number: NCT07044427
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Approximatly one third of the population over the age of 65 fall at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be carried out.

The aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)
• ECOG status ≤ 3
• Age ≥18 years
• Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits
• Ability to give informed consent
• Written consent to participate in the study
• Sufficient written and spoken German to complete the questionnaire

Exclusion Criteria

• Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectivity (fear of falling)	Evaluated at the beginning of the study and at the end of the study after 6 months	Fear of falling will be evaluated by a validated questionnaire (FES-I, Falls Efficacy Scale-Inernational). The questionnaire contains 16 items scored on a four-point scale (1=not at all concerned to 4=very concerned). Scores \>23 indicate high concern about falling.
Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks	From enrollement to the end of the training intervention at 6 months	Patients will document the number of training sessions via an online training-app (Physiotec, Bad Wünnenberg, Germany). Feasibility is achieved if 48 of 72 possible training sessions were successfully completed.

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden Würtemberg, Germany