Multiple SclerosisNCT04002492
Effects of a Weight Based Training Program on MS Patients
A study testing Bodyweight training in people with Multiple Sclerosis, run by Holy Name Medical Center, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Bodyweight training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Weight Based Training Program on Bone Density, Cognition, and Quality of Life of Multiple Sclerosis Patients
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.
Read the 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
- Being tested
- Bodyweight training
- Keywords
- sarcopenia, osteopenia, exercise, body weight training, bone density, demyelination, cognition
- Medical subject headings
- Multiple Sclerosis, Sarcopenia, Bone Diseases, Metabolic, Motor Activity, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyweight trainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Bodyweight training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 to 16 weeks
Secondary outcomes (2)
Depression and Quality of Life: MSIS (Multiple Sclerosis impact scale) survey/questionnaire
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).
Measured: 14 to 16 weeks
Cognition
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.
Measured: 14 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2019
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Name Medical Center, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Principal investigator, Mary Ann Picone, MD, Holy Name Medical Center, Inc.
- Investigators
- Mary Ann Picone, Principal investigator, Holy Name Medical Center Multiple Sclerosis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002492
- Sponsor's protocol ID
- US-MSG-17-11209
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Based Training Program on Bone Density, Cognition, and Quality of Life of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04002492
- Acronym / sponsor ID
- US-MSG-17-11209
- Conditions
- Multiple Sclerosis
- Keywords
- sarcopenia, osteopenia, exercise, body weight training, bone density, demyelination, cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Holy Name Medical Center, Inc.University, hospital or other
- Collaborators
- Biogen
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Addition of bodyweight training | Experimental | Behavioral: Bodyweight trainingAll 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodyweight trainingVideo 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. | Behavioural | Addition of bodyweight training |
Primary outcome
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.
2 secondary outcomes
Depression and Quality of Life: MSIS (Multiple Sclerosis impact scale) survey/questionnaire
Time frame: 14 to 16 weeks
Cognition
Time frame: 14 to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Ann Picone principal investigator
Holy Name Medical Center Multiple Sclerosis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodyweight training in people with Multiple Sclerosis, run by Holy Name Medical Center, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteopenia (time frame: 14 to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.