Effects of a Weight Based Training Program on MS Patients

NCT04002492 | Unknown

• 1 other identifier: US-MSG-17-11209
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

sarcopenia; osteopenia; exercise; body weight training; bone density; demyelination; cognition

Outcome Measures

Primary Outcomes (1)

• Osteopenia

  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.

  14 to 16 weeks

Secondary Outcomes (2)

• Depression and Quality of Life: MSIS (Multiple Sclerosis impact scale) survey/questionnaire

  14 to 16 weeks

• Cognition

  14 to 16 weeks

Study Arms (1)

Addition of bodyweight training

EXPERIMENTAL

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

Interventions

Bodyweight training 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.

Addition of bodyweight training

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holy Name Medical Center, Inc.: lead
• Biogen: collaborator

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sarcopenia; Bone Diseases, Metabolic; Motor Activity; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Mary Ann Picone

  Holy Name Medical Center Multiple Sclerosis Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Holy Name Comprehensive Care Center

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)