Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300335
Recruitment Status : Suspended (Due to COVID-19 and the fact that the study participants are part of the "high-risk" population, the start of the recruiting process has been delayed at will.)
First Posted : March 9, 2020
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Crevenna, 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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Other: Individual Exercise Other: Group Exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. VO2max [ Time Frame: Baseline + 12 weeks ]
    Maximum oxygen consumption in a cardiopulmonary exercise testing

  2. Handgrip Strength (HGS) [ Time Frame: Baseline + 12 weeks ]
    Handgrip Dynamometer (JAMAR)

  3. Six Minute Walk Test (6MWT) [ Time Frame: Baseline + 12 weeks ]
    Distance covered when walking as fast as possible in six minutes

  4. Tinetti-Test/Performance Oriented Mobility Assessment (POMA) [ Time Frame: Baseline + 12 weeks ]
    Risk of Fall Assessment

  5. Timed up and Go Test (TUG) [ Time Frame: Baseline + 12 weeks ]
    Risk of Fall Assessment

  6. Bioimpedance Analysis (BiA) [ Time Frame: Baseline + 12 weeks ]
    Body Composition measurement measured with Nutribox (BiA)

  7. 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)


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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

  7. Work Ability Index (WAI) [ Time Frame: Baseline + 12 weeks ]
    Work Ability (Questionnaire); Score range 1-10; higher scores indicating higher work ability

  8. 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

  9. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300335


Locations
Layout table for location information
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Richard Crevenna, Prof. MD Medical University of Vienna
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Richard Crevenna, Univ.-Prof. Dr. Richard Crevenna, MBA, MMSc, Head of the Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04300335    
Other Study ID Numbers: 2172/2019
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Crevenna, Medical University of Vienna:
exercise
fracture risk
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases