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

NCT ID: NCT07044427

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma Fall Risk Factors Strength Training Effects Balance Training Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise Intervention

Fall Prevention

Group Type OTHER

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

Intervention Type 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.

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bethanien Krankenhaus gGmbH

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Ulrike Dapunt

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dapunt

Role: STUDY_CHAIR

University Hospital Heidelberg

Locations

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University Hospital Heidelberg

Heidelberg, Baden Würtemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrike Dapunt, prof. Dr. med

Role: CONTACT

+49 622156 32765

Facility Contacts

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Ulrike Dapunt, Prof. Dr. med

Role: primary

+49 622156 32765

References

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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.

Reference Type BACKGROUND
PMID: 29239009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25454770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37727991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27450557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26907564 (View on PubMed)

Other Identifiers

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S-045/2024

Identifier Type: -

Identifier Source: org_study_id

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