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

Effects of a Weight Based Training Program on MS Patients

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: NCT04002492
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Mary Ann Picone, MD, Holy Name Medical Center, Inc.

Tracking Information
First Submitted Date  ICMJE June 14, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
Osteopenia [ Time Frame: 14 to 16 weeks ]
Change in bone density due to the addition of two bodyweight training sessions per week for a six 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, between weeks 14 and 16 depending on participant training schedule.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • 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 bodyweight training sessions per week for a six 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 bodyweight training sessions per weeks for a six 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Weight Based Training Program on MS Patients
Official Title  ICMJE Effects of a Weight Based Training Program on Bone Density, Cognition, and Quality of Life of Multiple Sclerosis Patients
Brief Summary Low bone density is a health risk in older adults and especially people with multiple sclerosis (MS) due to steroid treatments and less mobility. Bone density is a measurement of how dense or strong bones are. Weight-based training may be one method in strengthening bones and providing a beneficial treatment for MS patient rehabilitation. Weight based training involves performing exercises without the use of actual weights, and instead with one's own bodyweight. This study aims to look at the effects of weight-based training on bone density, cognition (ability to learn and understand), and other quality of life issues (i.e. depression) in MS patients.
Detailed Description This study aims to observe if there is a correlation between increasing one's physical activity levels via a bodyweight exercise program and a change in bone density, cognition, and quality of live for patients diagnosed with Multiple Sclerosis. The subjects enrolled in this study will perform a six week training cycle which includes one session per week located at Holy Name Medical Center (physical therapy department) as well as one session per week performed at the subject's home (video guide will be distributed). The training sessions should take approximately 30 minutes and include 3 sets of 10 repetitions for each of the individual exercises. There are five unchanging exercises that will be performed at each training session which include: wall push ups, chair squats, chair dips, step ups, and calf raises. Each subject will be required to perform both training sessions per week for six weeks. The following two weeks are set aside for make up dates for any missed training sessions if needed. During this six to eight week training (treatment) phase, one of the study investigators will remain in contact with the subjects of the study as to ensure commitment of at home training sessions. Prior to the training phase of this study, each subject will have a bone density DEXA scan performed and must complete SDMT (symbol digit modalities test) and MSIS-29 (multiple sclerosis impact scale) evaluations. Both the SDMT and MSIS-29 evaluations with be filled out again within two weeks of the completion of the training phase. 8 weeks after completion of the training phase of the study, each subject will return for a second bone density DEXA scan as well as complete both the SDMT and MSIS-29 evaluations for a third time. The duration of the study will fall between 14 and 16 weeks for any given participant depending on if the additional two weeks are needed to complete the training (treatment) phase. Previous research in this area have supported that bodyweight exercise had a positive impact on fatigue, muscle strength, and balance. Improvements in quality of life as well as cognition have also been documented by MS patients after performing exercise regimen. Because of the positive effects of exercise on patients with MS, the investigators in this study investigated the effects of weight-based training on bone density, cognition, depression, and quality of life in MS patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Bodyweight training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Diagnosis of RRMS, PPMS, SPMS, or CIS per the 2010 McDonald's criteria [Polman 2011].
  • Baseline EDSS score less than 5.5

Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Inability to read or understand English.
  • Any contraindication to perform weight-based training exercises.
  • Use of any supplemental human growth hormone, performance enhancing drug, or anabolic (non-clinical) steroid.
  • Participant has become or intends on becoming pregnant.
  • Participant has had a relapse in the past 6 months.
  • Patients who currently exercise more than three times per week.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002492
Other Study ID Numbers  ICMJE US-MSG-17-11209
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Ann Picone, MD, Holy Name Medical Center, Inc.
Study Sponsor  ICMJE Holy Name Medical Center, Inc.
Collaborators  ICMJE Biogen
Investigators  ICMJE
Principal Investigator: Mary Ann Picone Holy Name Medical Center Multiple Sclerosis Center
PRS Account Holy Name Medical Center, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP