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

Multiple Myeloma Clinical Trial

Official title:

The Feasibility and Effects of an Individualized Aerobic and Resistance Training Protocol for Patients Suffering From Multiple Myeloma With Varying Risk of Fall and Fracture - a Pilot Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04300335
• Other study ID #: 2172/2019
• Status: Suspended
• Phase: N/A
• Start date: March 2024
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

• Fulfillment of absolute exclusion criteria of the cardiovascular system or on the musculoskeletal system with regard to physical trainability
• Insufficient language knowledge
• Cognitively unable to follow the course of the study
• Severe mental illness

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Individual Exercise
Supervised body weight & resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
• Group Exercise
Supervised body weight & resistance band resistance exercises in a Group setting plus home based aerobic exercise

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Med Sci Sports Exerc. 2011 Jan;43(1):195. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)	Cancer specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Baseline + 12 weeks
Other	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)	Multiple myeloma specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Baseline + 12 weeks
Other	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)	Cancer related fatigue specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Baseline + 12 weeks
Other	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22)	Cancer related sexual health specific quality of life (Questionnaire); Score range from 0 to 100; A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.	Baseline + 12 weeks
Other	International Physical Activity Questionnaire (IPAQ)	Physical Activity (Questionnaire); Patients are asked about the frequency and volume of at least 10 minutes long episodes of vigorous and moderate physical activity during their last 7 days.; Higher values indicate higher levels of physical activity.	Baseline + 12 weeks
Other	Hospital Anxiety and Depression Scale (HADS)	Anxiety and Depression (Questionnaire); Score range from 0-21; lower scores indicating lower levels anxiety and depression	Baseline + 12 weeks
Other	Work Ability Index (WAI)	Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability	Baseline + 12 weeks
Other	Pittsburgh Sleep Quality Index (PSQI)	Sleep Quality (Questionnaire); score range from 0 to 21; lower scores indicating healthier sleep quality	Baseline + 12 weeks
Other	Falls Efficacy Scale (FES)	Fall Risk Assessment (Questionnaire); score range from 16 to 64; higher values indicate less fall-related self-efficacy (and more concern about falling).	Baseline + 12 weeks
Primary	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	VO2max	Maximum oxygen consumption in a cardiopulmonary exercise testing	Baseline + 12 weeks
Secondary	Handgrip Strength (HGS)	Handgrip Dynamometer (JAMAR)	Baseline + 12 weeks
Secondary	Six Minute Walk Test (6MWT)	Distance covered when walking as fast as possible in six minutes	Baseline + 12 weeks
Secondary	Tinetti-Test/Performance Oriented Mobility Assessment (POMA)	Risk of Fall Assessment	Baseline + 12 weeks
Secondary	Timed up and Go Test (TUG)	Risk of Fall Assessment	Baseline + 12 weeks
Secondary	Bioimpedance Analysis (BiA)	Body Composition measurement measured with Nutribox (BiA)	Baseline + 12 weeks
Secondary	Five Repetitions Sit-to-Stand Test (5STS)	Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)	Baseline + 12 weeks

External Links

•   Austrian Cancer Statistics Plasmocytoma/Myeloma