Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.
Trial design
Design model
Single group
Treatments tested in this trial
Strength and balance training in combination with a treadmill-based pertubation intervention
Other interventionPatients 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Exercise InterventionOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollement to the end of the training intervention at 6 months2
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.
Time frame
Evaluated at the beginning of the study and at the end of the study after 6 monthsSponsors and contacts
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University Hospital Heidelberg
Lead sponsor
Bethanien Krankenhaus gGmbH
Collaborator
Source ClinicalTrials.gov