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临床试验/NCT04300335
NCT04300335暂停不适用

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

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
45
试验地点
2
主要终点
Feasibility (Adherence)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Feasibility (Adherence)

时间窗: 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.

次要结局

  • Timed up and Go Test (TUG)(Baseline + 12 weeks)
  • Bioimpedance Analysis (BiA)(Baseline + 12 weeks)
  • Handgrip Strength (HGS)(Baseline + 12 weeks)
  • Six Minute Walk Test (6MWT)(Baseline + 12 weeks)
  • Five Repetitions Sit-to-Stand Test (5STS)(Baseline + 12 weeks)
  • VO2max(Baseline + 12 weeks)
  • Tinetti-Test/Performance Oriented Mobility Assessment (POMA)(Baseline + 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Crevenna

Univ.-Prof. Dr. Richard Crevenna, MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine

Medical University of Vienna

研究点 (2)

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