Strength Training in Improving Quality of Life in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03793907|
Recruitment Status : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Other: Control Group Other: Questionnaire Administration Other: Strenght Training||Not Applicable|
I. To assess the feasibility of a 6 month, twice weekly supervised strength training or a control intervention in patients with multiple myeloma.
I. To assess the adherence rate of the two groups (supervised strength training versus control) during the 6 month intervention programs.
II. To assess the eligibility and recruitment rate for the trial among patients with multiple myeloma.
I. Comparison of disease activity parameters, physical activity level, clinical symptoms, medication, psycho-oncological parameters, body composition and immune status between the intervention and control group.
II. Determine factors that may influence a persons? willingness to participate in the trial.
III. Compare the bone density (acquired by dual energy x-ray absorptiometry [DEXA] scan) before and after intervention.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete strength training over 1 hour twice weekly for 6 months.
ARM II: Patients receive standard of care.
After completion of study, patients are followed up for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility of Strength Training and Impact on Bone Health, Pain, and Quality of Life in Patients With Multiple Myeloma|
|Estimated Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||October 11, 2021|
|Estimated Study Completion Date :||October 11, 2022|
Experimental: Arm I (strength training)
Patients complete strength training over 1 hour twice weekly for 6 months.
Other: Questionnaire Administration
Other: Strenght Training
Twice a week strength training for 6 months
Other Name: Resistance Training
Active Comparator: Arm II (standard of care)
Patients receive standard of care.
Other: Control Group
To perform activities of daily living according to the discretion of an orthopedic or neurosurgeon.
Other: Questionnaire Administration
- Feasibility rate [ Time Frame: At 6 months ]Will be defined as the proportion of randomized patients in the intervention group who are still on study at the end of 6 months as compared to the control group.
- Adherence rate [ Time Frame: At 6 months ]Will be defined as the proportion of patients remaining on study at 6 months who complete >= 80% of the intervention activities. In the control group adherence will be assessed according to patients taking part in the diagnostic procedures.
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): NCT03793907
|United States, New York|
|Roswell Park Cancer Institute||Not yet recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Jens Hillengass 716-845-3221 Jens.Hillengass@roswellpark.org|
|Principal Investigator: Jens Hillengass|
|Principal Investigator:||Jens Hillengass||Roswell Park Cancer Institute|