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

October 18, 2023 updated by: Richard Crevenna, Medical University of Vienna

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Individual Exercise
Supervised body weight & resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
Experimental: 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.
Other: Group Exercise
Supervised body weight & resistance band resistance exercises in a Group setting plus home based aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Adherence)
Time Frame: Adherence rates through 12 weeks of exercise intervention program
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2max
Time Frame: Baseline + 12 weeks
Maximum oxygen consumption in a cardiopulmonary exercise testing
Baseline + 12 weeks
Handgrip Strength (HGS)
Time Frame: Baseline + 12 weeks
Handgrip Dynamometer (JAMAR)
Baseline + 12 weeks
Six Minute Walk Test (6MWT)
Time Frame: Baseline + 12 weeks
Distance covered when walking as fast as possible in six minutes
Baseline + 12 weeks
Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
Time Frame: Baseline + 12 weeks
Risk of Fall Assessment
Baseline + 12 weeks
Timed up and Go Test (TUG)
Time Frame: Baseline + 12 weeks
Risk of Fall Assessment
Baseline + 12 weeks
Bioimpedance Analysis (BiA)
Time Frame: Baseline + 12 weeks
Body Composition measurement measured with Nutribox (BiA)
Baseline + 12 weeks
Five Repetitions Sit-to-Stand Test (5STS)
Time Frame: Baseline + 12 weeks
Test for Lower Extremity Strength (time needed to stand up and sit down on a chair 5 times)
Baseline + 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)
Time Frame: Baseline + 12 weeks
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
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)
Time Frame: Baseline + 12 weeks
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
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)
Time Frame: Baseline + 12 weeks
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
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22)
Time Frame: Baseline + 12 weeks
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
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline + 12 weeks

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
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline + 12 weeks
Anxiety and Depression (Questionnaire); Score range from 0-21; lower scores indicating lower levels anxiety and depression
Baseline + 12 weeks
Work Ability Index (WAI)
Time Frame: Baseline + 12 weeks
Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability
Baseline + 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline + 12 weeks
Sleep Quality (Questionnaire); score range from 0 to 21; lower scores indicating healthier sleep quality
Baseline + 12 weeks
Falls Efficacy Scale (FES)
Time Frame: Baseline + 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Richard Crevenna, Prof. MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2172/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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