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NCT Number: NCT07044427

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

Approximately one third of the population over the age of 65 falls 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 implemented.

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.

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Key information

Conditions

Multiple Myeloma Balance Training Effects Blood Protein Disorders Cardiovascular Diseases Fall Risk Factors Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Strength Training Effects Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg

Heidelberg, Baden Würtemberg, 69120, Germany

Location status: Recruiting

Location contact

Ulrike Dapunt, Prof. Dr. med

CONTACT

[email protected]

+49 622156 32765

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strength and balance training in combination with a treadmill-based pertubation intervention

Other

Patients receive a personalized home-based training plan with strength and balance exercises to be carried out three times a week for six months. In addition, treadmill-based pertubation training is carried out at 2 timepoints.

Primary outcomes

  1. Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks

    Time frame: 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.

  2. Effectivity (fear of falling)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ulrike Dapunt, prof. Dr. med

CONTACT

[email protected]

+49 622156 32765

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • Bethanien Krankenhaus gGmbH

Registry information

Official study title

Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma

Acronym: Myfall

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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