Clinical trial NCT04002492: Effects of a Weight Based Training Program on MS Patients
Official title: Effects of a Weight Based Training Program on Bone Density, Cognition, and Quality of Life of Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: sarcopenia
osteopenia
exercise
body weight training
bone density
demyelination
cognition
Lead sponsor: Holy Name Medical Center, Inc.
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2019-06-28
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Osteopenia
timeFrame: 14 to 16 weeks
Secondary outcomes:
measure: Depression and Quality of Life: MSIS (Multiple Sclerosis impact scale) survey/questionnaire
timeFrame: 14 to 16 weeks
measure: Cognition
timeFrame: 14 to 16 weeks
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
Study officials:
affiliation: Holy Name Medical Center Multiple Sclerosis Center
name: Mary Ann Picone
role: PRINCIPAL_INVESTIGATOR
References: