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

Not Applicable

Suspended

• Conditions: Multiple Myeloma
• Interventions: Other: Individual Exercise; Other: Group Exercise

• Registration Number: NCT04300335
• Lead Sponsor: Medical University of Vienna

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.

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 Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2024-03
• Primary Completion: 2024-10
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Risk - Individual Exercise	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.
Low Risk - Group Exercise	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.

Primary Outcome Measures

Name	Time	Method
Feasibility (Adherence)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria