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

NCT04300335 | Suspended

• 1 other identifier: 2172/2019
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

exercise; fracture risk

Outcome Measures

Primary Outcomes (1)

• Feasibility (Adherence)

  We hypothesize that the adherence of "High Risk Patients" to a personal, individualized exercise intervention is equal to that of "Low Risk Patients" performing group exercise.

  Adherence rates through 12 weeks of exercise intervention program

Secondary Outcomes (7)

• VO2max

  Baseline + 12 weeks

• Handgrip Strength (HGS)

  Baseline + 12 weeks

• Six Minute Walk Test (6MWT)

  Baseline + 12 weeks

• Tinetti-Test/Performance Oriented Mobility Assessment (POMA)

  Baseline + 12 weeks

• Timed up and Go Test (TUG)

  Baseline + 12 weeks

Other Outcomes (9)

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)

  Baseline + 12 weeks

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)

  Baseline + 12 weeks

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)

  Baseline + 12 weeks

Study Arms (2)

High Risk - Individual Exercise

EXPERIMENTAL

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.

Other: Individual Exercise

Low Risk - Group Exercise

EXPERIMENTAL

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

Other: Group Exercise

Interventions

Individual Exercise OTHER

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

High Risk - Individual Exercise

Group Exercise OTHER

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

Low Risk - Group Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Insufficient language knowledge
• Cognitively unable to follow the course of the study
• Severe mental illness

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (8)

• 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.

  PMID: 30539278 BACKGROUND

• 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.

  PMID: 23569317 BACKGROUND

• 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.

  PMID: 24157580 BACKGROUND

• 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.

  PMID: 11879296 BACKGROUND

• 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.

  PMID: 30686037 BACKGROUND

• 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.

  PMID: 26441078 BACKGROUND

• 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.

  PMID: 20559064 BACKGROUND

• 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.

  PMID: 31784826 BACKGROUND

Related Links

• Austrian Cancer Statistics Plasmocytoma/Myeloma

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity

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; Behavior

Study Officials

• Richard Crevenna, Prof. MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. Richard Crevenna, MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Model Details: 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)

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

AU (1)