Effects of a Weight Based Training Program on MS Patients
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|ClinicalTrials.gov Identifier: NCT04002492|
Recruitment Status : Unknown
Verified August 2019 by Mary Ann Picone, MD, Holy Name Medical Center, Inc..
Recruitment status was: Enrolling by invitation
First Posted : June 28, 2019
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Bodyweight training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of a Weight Based Training Program on Bone Density, Cognition, and Quality of Life of Multiple Sclerosis Patients|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Addition of bodyweight training
All participants in this study fall into this non randomized single group. These participants will complete a total of 12 bodyweight training sessions over a six to eight week time period. Participants will attend one session per week at Holy Name Medical Center's Physical Therapy Center and will train for one session at their home or chosen location with the aid of a video guide.
Behavioral: Bodyweight training
Video guided and physical therapist guided bodyweight training sessions will be performed twice a week for 6 (to 8) weeks. These sessions include the following five workouts at 3 sets of 10 repetitions: step ups, calf raises, wall push ups, chair squats, and chair dips.
- Osteopenia [ Time Frame: 14 to 16 weeks ]Change in bone density due to the addition of two body weight training sessions per week for a six (to eight) week time period. Bone density will be measured via a DEXA bone density scan at day one of the trial and a secondary DEXA scan taking place eight weeks after the final training session. The duration of this aspect of the study falls between 14 and 16 weeks depending on participant training schedule and if rescheduled or make up training sessions are needed.
- Depression and Quality of Life: MSIS (Multiple Sclerosis impact scale) survey/questionnaire [ Time Frame: 14 to 16 weeks ]Change in the study participants' view of depression and quality of life pertaining to their MS due to the addition of two body weight training sessions per week for a six (to eight) week time period. Depression and quality of life will be recorded via an (MSIS-29) Multiple Sclerosis Impact Scale survey/questionnaire. This questionnaire consists of 29 items dealing with both the physical and psychological impact of Multiple Sclerosis from a participant's perspective. The MSIS-29 is scored between 29 and 145 in which a higher value indicates a greater impact of MS from a subject's perspective. This questionnaire will be completed by participants on day one of the trial, within two weeks of the completion of their training sessions (between weeks 6 and 10), and eight weeks after their final training session (between weeks 14-16).
- Cognition [ Time Frame: 14 to 16 weeks ]Change in cognition due to the addition of two body weight training sessions per weeks for a six (to eight) week time period. Cognition will be measured using an SDMT (symbol digit modalities test) on day one of the trial, within two weeks of the completion the final training session (between weeks 6 and 10), and eight weeks after the completion of the final training session (between weeks 14 and 16). The duration of this aspect of the study falls between 14 and 16 weeks depending on participant training schedule and if rescheduled or make up training sessions are needed.
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): NCT04002492
|United States, New Jersey|
|Holy Name Medical Center|
|Teaneck, New Jersey, United States, 07666|
|Principal Investigator:||Mary Ann Picone||Holy Name Medical Center Multiple Sclerosis Center|