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

NCT07044427 | Recruiting

• 1 other identifier: S-045/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma; Fall Risk Factors; Strength Training Effects; Balance Training Effects

Keywords

Multiple Myeloma; Fall risk; pertubation training; strength training; Balance

Outcome Measures

Primary Outcomes (2)

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

  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.

  From enrollement to the end of the training intervention at 6 months

• Effectivity (fear of falling)

  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.

  Evaluated at the beginning of the study and at the end of the study after 6 months

Study Arms (1)

Exercise Intervention

OTHER

Fall Prevention

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

Interventions

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.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Bethanien Krankenhaus gGmbH: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Baden Würtemberg, 69120, Germany

RECRUITING

Related Publications (5)

• Wildes TM, Fiala MA. Falls in older adults with multiple myeloma. Eur J Haematol. 2018 Mar;100(3):273-278. doi: 10.1111/ejh.13009. Epub 2018 Jan 8.

  PMID: 29239009 BACKGROUND

• Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S. Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30.

  PMID: 25454770 BACKGROUND

• Dapunt U, Ehret P, Paratte JL, Kuehl RM, Wiskemann J, Jager D, Muller-Tidow C, Raab MS, Goldschmidt H. A precision-based exercise program for patients with multiple myeloma. Eur J Haematol. 2023 Dec;111(6):930-937. doi: 10.1111/ejh.14106. Epub 2023 Sep 20.

  PMID: 37727991 BACKGROUND

• Sattar S, Alibhai SM, Spoelstra SL, Fazelzad R, Puts MT. Falls in older adults with cancer: a systematic review of prevalence, injurious falls, and impact on cancer treatment. Support Care Cancer. 2016 Oct;24(10):4459-69. doi: 10.1007/s00520-016-3342-8. Epub 2016 Jul 22.

  PMID: 27450557 BACKGROUND

• Pandya C, Magnuson A, Dale W, Lowenstein L, Fung C, Mohile SG. Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study. J Geriatr Oncol. 2016 May;7(3):201-10. doi: 10.1016/j.jgo.2016.01.007. Epub 2016 Feb 18.

  PMID: 26907564 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dapunt

  University Hospital Heidelberg

  STUDY CHAIR

Central Study Contacts

Ulrike Dapunt, prof. Dr. med

CONTACT

+49 622156 32765; ulrike.dapunt@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 1, 2025
• Study Start: February 2, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)