The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma

NCT ID: NCT04300335

Last Updated: 2025-10-01

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-12-31

Brief Summary

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Multiple myeloma is the second most common haematological cancer with a cancer incidence of around 500 new cases in Austria per year . Novel treatment methods have significantly increased the cancer-specific survival rate in patients with multiple myeloma. For Austria, this means that 5- and 10-year survival rates rose from 32.1 to 46.4% and from 19.0 to 25.6% from the end of the 1980s to the end of the 2000s.

Longer survival is associated with the need to maintain independence and quality of life in the longer term. In this context, regular physical training has seen a significant increase in the importance of cancer in recent years.The guidelines of the American College of Sports Medicine still contain very general training recommendations for cancer patients. Either 150 minutes of moderate or 75 minutes of intensive endurance training per week are recommended, supplemented by at least two units of strengthening training and stretching exercises for the large muscle groups.

In a recent cross-sectional and pilot study with multiple myeloma patients that was carried out at the Clinic for Physical Medicine, Rehabilitation and Occupational Medicine at the Medical University of Vienna (EK 1725/2018), it was on the one hand identified that there was a discrepancy between these patients on the one hand has given actual and perceived risk of falling, and on the other hand it is concluded that training recommendations should be carried out separately in group and individual training according to the actual risk of falling and fracture.

The present project is the follow-up to this cross-sectional investigation. The aim is to examine the feasibility and effects of a structured, physical training program carried out over a period of 12 weeks on physical performance, quality of life, body composition and the risk of falling. The effects of patients with increased risk in individual training sessions are compared to those of lower risk patients in group training sessions. Furthermore, the study patients will be able to bring training partners with them to their own training units if available and for their own security. They are evaluated separately according to qualitative criteria.

Detailed Description

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The aim of this study is to investigate the feasibility and effectiveness of individualized training support for multiple myeloma patient populations divided into high and low risk according to their fall and fracture risk. The primary hypothesis is that multiple myeloma patients who meet the criteria for a high risk of falling and / or fracture can achieve equivalent adherence rates and training effects through individually compiled individual training, such as multiple myeloma patients with low risk of falling who conduct group training.

The adherence rates are recorded via attendance lists for training and video conferences as well as a training diary for independent training. To record the training effects, physical performance and functionality are measured and the quality of life, sexuality, depression, fatigue, sleep quality, work ability and risk of falling are assessed using standardized, validated questionnaires.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Group 1: Individual exercise prescription (high fracture risk and/or high risk of fall patients) Group 2: Group exercise (low fracture risk and low risk of fall patients)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High Risk - Individual Exercise

Patients who show an increased fracture risk and/or increased risk of fall in the screening assessments and are therefore allocated to an individualized personal training.

Group Type EXPERIMENTAL

Individual Exercise

Intervention Type OTHER

Supervised body weight \& resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise

Low Risk - Group Exercise

Patients who show neither increased fracture risk nor increased risk of fall in the screening assessments and are therefore allocated to the exercise group.

Group Type EXPERIMENTAL

Group Exercise

Intervention Type OTHER

Supervised body weight \& resistance band resistance exercises in a Group setting plus home based aerobic exercise

Interventions

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Individual Exercise

Supervised body weight \& resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise

Intervention Type OTHER

Group Exercise

Supervised body weight \& resistance band resistance exercises in a Group setting plus home based aerobic exercise

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Multiple Myeloma after primary Treatment
* Sufficient knowledge of the German language to being able to follow the study procedures
* Cardiologic-internal clearance for exercise

Exclusion Criteria

* Insufficient language knowledge
* Cognitively unable to follow the course of the study
* Severe mental illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Richard Crevenna

Univ.-Prof. Dr. Richard Crevenna, MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Crevenna, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Radocha J, Hajek R, Brozova L, Pour L, Spicka I, Minarik J, Gregora E, Jungova A, Jelinek T, Heindorfer A, Sykora M, Maisnar V. Simplified novel prognostic score for real-life older adults with multiple myeloma-registry-based analysis. Ann Hematol. 2019 Apr;98(4):951-962. doi: 10.1007/s00277-018-3568-2. Epub 2018 Dec 11.

Reference Type BACKGROUND
PMID: 30539278 (View on PubMed)

Warren JL, Harlan LC, Stevens J, Little RF, Abel GA. Multiple myeloma treatment transformed: a population-based study of changes in initial management approaches in the United States. J Clin Oncol. 2013 Jun 1;31(16):1984-9. doi: 10.1200/JCO.2012.46.3323. Epub 2013 Apr 8.

Reference Type BACKGROUND
PMID: 23569317 (View on PubMed)

Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25.

Reference Type BACKGROUND
PMID: 24157580 (View on PubMed)

Mock V, Pickett M, Ropka ME, Muscari Lin E, Stewart KJ, Rhodes VA, McDaniel R, Grimm PM, Krumm S, McCorkle R. Fatigue and quality of life outcomes of exercise during cancer treatment. Cancer Pract. 2001 May-Jun;9(3):119-27. doi: 10.1046/j.1523-5394.2001.009003119.x.

Reference Type BACKGROUND
PMID: 11879296 (View on PubMed)

Crevenna R. Aspects of cancer rehabilitation: an Austrian perspective. Disabil Rehabil. 2020 Jan;42(1):1. doi: 10.1080/09638288.2018.1522554. Epub 2019 Jan 27. No abstract available.

Reference Type BACKGROUND
PMID: 30686037 (View on PubMed)

Crevenna R. Cancer rehabilitation and palliative care--two important parts of comprehensive cancer care. Support Care Cancer. 2015 Dec;23(12):3407-8. doi: 10.1007/s00520-015-2977-1. Epub 2015 Oct 6. No abstract available.

Reference Type BACKGROUND
PMID: 26441078 (View on PubMed)

Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.

Reference Type BACKGROUND
PMID: 20559064 (View on PubMed)

Cenik F, Keilani M, Hasenohrl T, Huber D, Stuhlpfarrer B, Pataraia A, Crevenna R. Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):124-131. doi: 10.1007/s00508-019-01582-z. Epub 2019 Nov 29.

Reference Type BACKGROUND
PMID: 31784826 (View on PubMed)

Related Links

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Other Identifiers

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2172/2019

Identifier Type: -

Identifier Source: org_study_id

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