Effects of a Weight Based Training Program on MS Patients

NCT ID: NCT04002492

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-31

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bodyweight training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Holy Name Medical Center, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Mary Ann Picone, MD

Medical Director of Holy Name Comprehensive Care Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Ann Picone

Role: PRINCIPAL_INVESTIGATOR

Holy Name Medical Center Multiple Sclerosis Center

Locations

Holy Name Medical Center

Teaneck, New Jersey, United States

Countries

United States

Other Identifiers

US-MSG-17-11209

Identifier Type: -

Identifier Source: org_study_id