Multiple Sclerosis Clinical Trial
Official title:
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
Verified date | February 2017 |
Source | University of Illinois at Urbana-Champaign |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to test the effectiveness of a DVD-delivered, home-based six-month physical activity intervention for people with Multiple Sclerosis.
Status | Completed |
Enrollment | 50 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - being non-active, defined as reporting not engaging in regular activity (30 minutes accumulated per day) on more than two days of the week in the prior six months; - aged 50 years and older; - fluent in English; - relapse-free in the last 30 days; - ambulatory with minimal assistance(i.e., walk independently or with a single-point assistive walking device such as a cane); - the provision of medical clearance for participation in a physical activity program by participants' physicians, along with a physician-confirmed diagnosis of MS (communication with physicians will be facilitated by research staff). Exclusion Criteria: - self-reported physical activity on a regular basis within the last six months (2 times or more per week); - younger than 50 years of age; - relapse in the last 30 days; - no regular access to a television; - no physician-confirmed diagnosis of multiple sclerosis; - unable to successfully score above 21 (out of 39)on the Telephone Interview of Cognitive Status questionnaire (TICS-M). |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Urbana-Champaign | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign | National Multiple Sclerosis Society |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis | The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance |
Baseline and six months | |
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS | Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible; |
Baseline and six-months | |
Primary | Change in assessments of functional fitness assessments in sedentary adults with MS | Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes; |
Baseline and six-months | |
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS | Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength; |
Baseline and six-months | |
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS | Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility) |
Baseline and six-months | |
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS | Measurements will include: Upper body strength -- bicep curls consisting of lifting a light hand-weight as many times as possible in 30-seconds; |
Baseline and six-months | |
Primary | Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS | Measurements will include: Balance -- a timed (up to 30-seconds) unassisted one-leg stand test with eyes open on each leg. |
Baseline and six-months | |
Primary | Change from baseline to six-months in assessments of reported quality of life in people with MS | The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS. | Baseline and six months | |
Primary | Change from baseline to six-months in assessments of reported quality of life in people with MS | The Satisfaction with Life Scale will be used to assess global life satisfaction and is sensitive enough to detect changes in participants' perceptions over the course of a clinical intervention. | Baseline and six-months | |
Secondary | Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS | The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance. | Baseline and six months | |
Secondary | Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS | Participants' situation-specific self-confidence for physical activity will be assessed using The Barriers Self-Efficacy Scale, which taps subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation. | Baseline and six months | |
Secondary | Changes in physical activity relating to specified exercise program in sedentary adults with MS | Adherence to exercise program as documented by daily exercise logs. | Baseline and six months | |
Secondary | Objective changes in physical activity in sedentary adults with MS | Objective assessment of physical activity via accelerometry over seven days time. | Baseline and six months | |
Secondary | Self-reported changes in physical activity in sedentary adults with MS | Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities. | Baseline and six months | |
Secondary | Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS | Participants' situation-specific self-confidence for physical activity will be assessed using The Gait Self-Efficacy Scale, which will assess participants' beliefs in their capabilities to negotiate stairs and objects in their path. | Baseline and six-months | |
Secondary | Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS | The Exercise Self-Efficacy Scale will assess participants' beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 40+ minutes per session in the future. | Baseline and six-months | |
Secondary | Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS | Walking Self-Efficacy Scale for Duration will assess participants' beliefs in their physical capability to successfully complete incremental 5-minute intervals (up to 40 minutes)of walking at a moderately fast pace. | Baseline and six-months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|