Clinical trial NCT04300335: The Feasibility and Effects of Exercise on Patients Suffering From Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Multiple Myeloma
Keywords: exercise
fracture risk
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (Adherence)
timeFrame: Adherence rates through 12 weeks of exercise intervention program
Secondary outcomes:
measure: VO2max
timeFrame: Baseline + 12 weeks
measure: Handgrip Strength (HGS)
timeFrame: Baseline + 12 weeks
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline + 12 weeks
measure: Tinetti-Test/Performance Oriented Mobility Assessment (POMA)
timeFrame: Baseline + 12 weeks
measure: Timed up and Go Test (TUG)
timeFrame: Baseline + 12 weeks
measure: Bioimpedance Analysis (BiA)
timeFrame: Baseline + 12 weeks
measure: Five Repetitions Sit-to-Stand Test (5STS)
timeFrame: Baseline + 12 weeks
Other outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30)
timeFrame: Baseline + 12 weeks
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20)
timeFrame: Baseline + 12 weeks
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12)
timeFrame: Baseline + 12 weeks
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22)
timeFrame: Baseline + 12 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline + 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline + 12 weeks
measure: Work Ability Index (WAI)
timeFrame: Baseline + 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline + 12 weeks
measure: Falls Efficacy Scale (FES)
timeFrame: Baseline + 12 weeks
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Richard Crevenna, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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