Multiple Myeloma
Conditions
Keywords
exercise, fracture risk
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.
Interventions
OTHERIndividual Exercise
Supervised body weight & resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
OTHERGroup Exercise
Supervised body weight & resistance band resistance exercises in a Group setting plus home based aerobic exercise
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Tinetti-Test/Performance Oriented Mobility Assessment (POMA) | Baseline + 12 weeks | Risk of Fall Assessment |
| VO2max | Baseline + 12 weeks | Maximum oxygen consumption in a cardiopulmonary exercise testing |
| Bioimpedance Analysis (BiA) | Baseline + 12 weeks | Body Composition measurement measured with Nutribox (BiA) |
| 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) |
| Timed up and Go Test (TUG) | Baseline + 12 weeks | Risk of Fall Assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Basic Module (EORTC QLQ-C30) | 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. |
| Falls Efficacy Scale (FES) | 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). |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Myeloma Module (EORTC QLQ-MY20) | 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. |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Fatigue Module (EORTC QLQ-FA12) | 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. |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Sexual Health Quality Module (EORTC QLQ-SHQ22) | 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. |
| International Physical Activity Questionnaire (IPAQ) | 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. |
| Hospital Anxiety and Depression Scale (HADS) | Baseline + 12 weeks | Anxiety and Depression (Questionnaire); Score range from 0-21; lower scores indicating lower levels anxiety and depression |
| Work Ability Index (WAI) | Baseline + 12 weeks | Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline + 12 weeks | Sleep Quality (Questionnaire); score range from 0 to 21; lower scores indicating healthier sleep quality |
Countries
Austria
Outcome results
None listed