Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341023
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-26
Brief Title:
Functional Balance Intervention in Multiple Sclerosis
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Functional Balance Intervention FBI for Physical and Cognitive Symptoms of Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FBIinMS
Brief Summary:
This project involves two sub-parts
Study 1 Effect of lab-based Functional Balance Intervention FBI for physical and cognitive symptoms of Multiple Sclerosis
Study 2 Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis
Each study involves a 2-arm Phase-1 randomized controlled clinical trial to evaluate the effect of FBI on physical cognitive function and daily living among people with MS PwMS Study 1 is conducted in a lab setting while Study 2 is conducted at home with additional safety measures A total of 150 people with multiple sclerosis will be recruited and telephone screened with an expected enrollment of 120 60 per phase After in-person screening 96 eligible participants 48 per phase will undergo pre-training assessment and randomization into FBI or Stretching groups Training sessions will occur twice a week for four months Anticipating a 15-17 attrition rate the target sample size is 80 40 per phase for completion of the study Post-training assessments will be conducted after four months to evaluate FBIs impact on physical and cognitive functions This evidence-based protocol previously successful with neurological and older adult populations intends to provide a low-cost safe and effective intervention for PwMS in clinical and community settings including rural areas
Study 1 Effect of lab-based Functional Balance Intervention FBI for physical and cognitive symptoms of Multiple Sclerosis
Study 2 Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis
Each study involves a 2-arm Phase-1 randomized controlled clinical trial to evaluate the effect of FBI on physical cognitive function and daily living among people with MS PwMS Study 1 is conducted in a lab setting while Study 2 is conducted at home with additional safety measures A total of 150 people with multiple sclerosis will be recruited and telephone screened with an expected enrollment of 120 60 per phase After in-person screening 96 eligible participants 48 per phase will undergo pre-training assessment and randomization into FBI or Stretching groups Training sessions will occur twice a week for four months Anticipating a 15-17 attrition rate the target sample size is 80 40 per phase for completion of the study Post-training assessments will be conducted after four months to evaluate FBIs impact on physical and cognitive functions This evidence-based protocol previously successful with neurological and older adult populations intends to provide a low-cost safe and effective intervention for PwMS in clinical and community settings including rural areas
Detailed Description:
10 BACKGROUNDSCIENTIFIC RATIONALE Study 1 and 2 Of the 1 million adults living with multiple sclerosis MS in the United States over 80 have physical impairment an estimated 45-60 have cognitive impairment and 20-30 will develop severe dementia Physical deficits include muscular weakness spasticity sensorimotor dysfunction and imbalance which co-occur with cognitive dysfunction and directly impact community mobility and overall quality of life Cognitive deficits include slowed processing speed and reaction time poor executive functions like planning and problem-solving and learning and memory deficits Physical and cognitive deficits rarely remit after onset and are associated with secondary problems with mobility and balance resulting in increased fall-risk Whereas treatments targeting restoration of physical function in PwMS have been established research informing effective management of cognitive dysfunction is in its early stages Further there is limited evidence for pharmacological and rehabilitation approaches that can target both physical and cognitive dysfunction Yet there have been recent calls for greater focus on unique modes of exercise training as the most promising approach
Exercise training interventions have yielded modest but consistent improvements in physical function walking ability and fatigue in PwMS Whereas there is extensive evidence on exercise training targeting physical function there is comparatively much less known about exercise training targeting cognitive function in PwMS and this literature is not yet conclusive Additionally previous interventions among PwMS have rarely incorporated components of functional balance for treating physical and cognitive dysfunction Interventions like aerobic andor strength training are effective in improving physical function yet effects on cognitive dysfunction might not be very robust Indeed cognitive improvements after protocols of aerobic andor strength-based exercise training might be limited because these modalities might share limited brain resources with physical domains and cognitive tasks resulting in only a minor transfer of improvements to physical and cognitive performance On the other hand there is more evidence of common neural resources shared between cognitive tasks and balance control eg vestibular visuospatial processing executive function attention Thus focusing on functional balance training could have a greater activation of the central nervous system CNS integrative frameworks for treating cognitive dysfunction in PwMS It could further have secondary benefits of improving fall efficacy physical activity and community mobility thereby mediating change in measures of quality of life among PwMS Thus the investigators propose a novel multicomponent exercise intervention named Functional Balance Intervention FBI for improving physical and cognitive function and other measures of daily living among PwMS The effects of FBI will be tested in a laboratory setting Study 1 and then tested in a home-based setting Study 2 in parallel For both studies the FBI will be compared to a control group who will complete an equivalent dosage of stretching Results from the proposed Phase-I Randomized Controlled Trial RCT will inform the research community to launch a line of larger Phase-II RCT examining the comparative effectiveness of the FBI program among PwMS The findings from this project can also serve as preliminary groundwork for conducting large-scale clinical trials to assess comparative effectiveness of FBI with other pre-established interventions particularly for individuals with restricted mobility andor restricted access to onsite healthcare services
20 OBJECTIVES Study 1 and 2 The two-study project is an alternative non-pharmacological intervention which represents an important avenue for treating physical and cognitive symptoms of MS and aims to impact measures of mobility and quality of life Through this project the investigators will simultaneously examine the effects of FBI compared to stretching among PwMS in a lab-based setting Study 1 and home-based setting Study 2 Study 1 and 2 will run in parallel ie all data collection analysis and dissemination activities will occur simultaneously For both studies the investigators first postulate that a Functional Balance Intervention FBI can result in immediate improvements in physical function possibly mediated via improvements in secondary endpoints of dual-task balance functional mobility and gait Secondly the investigators postulate the possibility that cognition shares more similar neural processes with balance control than with other functional domains such that CNS adaptations induced by functional balance training could translate into immediate in cognition40 The improvements in physical and cognitive function will mediate improvements in other measures of daily living
Below are the combined specific aims for Study 1 and 2
Aim 1 Examine the effect of the FBI Intervention Group on physical function in PwMS compared to a stretching program Control Group
Hypothesis 1 After 4 months of training the FBI will show significantly higher improvements in physical function compared to the stretching
Aim 2 Examine the effect of a multicomponent FBI on cognitive function compared to PwMS in the stretching program
Hypothesis 2 After 4 months of training the FBI will show significantly higher improvements in cognitive function compared to the stretching
Aim 3 Examine the effects of the multicomponent FBI compared to the control group among PwMS on measures of daily living dual task performance balance confidence community mobility and quality of life
Hypothesis 3 After 4 months of training the FBI will show significantly higher improvements in measures of daily living compared to stretching
30 Research Design Both sub-studies included in this project ie Study 1 and 2 involve a randomized controlled trial design to establish the feasibility and initial effect of a multicomponent Functional Balance Intervention FBI for immediate improvements in physical and cognitive function and measures of daily living among persons with multiple sclerosis PwMS Study 1 will include training sessions in the lab and Study 2 will include training sessions at home Data collection procedures for Study 1 and 2 will run in parallel
A total sample of 120 participants with Multiple Sclerosis 60 in each study will be enrolled in this project The investigators expect 20 in-person screening failures Hence the investigators expect that 96 PwMS will be eligible to be included in the study undergo pre-training assessment and then randomized into 2 groups The Interventional Group n24 for Study 1 and n24 for Study 2 will undergo a multi component Functional Balance Intervention for 4 months whereas in the Control Group n24 for Study 1 and n24 for Study 2 will receive a stretching intervention for 4 months
Study overview Study 1 and 2 All participants will undergo the following procedures
Week 1 Recruitment and phone screening
Week 2 In-person screening 2 hours
Week 3 Pre-training assessment 2 hours
Week 4 Random Assignment
Week 5-20 Training sessions 1 hourday 2 times per week for 4 months
Week 21 Post-training assessment 2 hours
Exercise training interventions have yielded modest but consistent improvements in physical function walking ability and fatigue in PwMS Whereas there is extensive evidence on exercise training targeting physical function there is comparatively much less known about exercise training targeting cognitive function in PwMS and this literature is not yet conclusive Additionally previous interventions among PwMS have rarely incorporated components of functional balance for treating physical and cognitive dysfunction Interventions like aerobic andor strength training are effective in improving physical function yet effects on cognitive dysfunction might not be very robust Indeed cognitive improvements after protocols of aerobic andor strength-based exercise training might be limited because these modalities might share limited brain resources with physical domains and cognitive tasks resulting in only a minor transfer of improvements to physical and cognitive performance On the other hand there is more evidence of common neural resources shared between cognitive tasks and balance control eg vestibular visuospatial processing executive function attention Thus focusing on functional balance training could have a greater activation of the central nervous system CNS integrative frameworks for treating cognitive dysfunction in PwMS It could further have secondary benefits of improving fall efficacy physical activity and community mobility thereby mediating change in measures of quality of life among PwMS Thus the investigators propose a novel multicomponent exercise intervention named Functional Balance Intervention FBI for improving physical and cognitive function and other measures of daily living among PwMS The effects of FBI will be tested in a laboratory setting Study 1 and then tested in a home-based setting Study 2 in parallel For both studies the FBI will be compared to a control group who will complete an equivalent dosage of stretching Results from the proposed Phase-I Randomized Controlled Trial RCT will inform the research community to launch a line of larger Phase-II RCT examining the comparative effectiveness of the FBI program among PwMS The findings from this project can also serve as preliminary groundwork for conducting large-scale clinical trials to assess comparative effectiveness of FBI with other pre-established interventions particularly for individuals with restricted mobility andor restricted access to onsite healthcare services
20 OBJECTIVES Study 1 and 2 The two-study project is an alternative non-pharmacological intervention which represents an important avenue for treating physical and cognitive symptoms of MS and aims to impact measures of mobility and quality of life Through this project the investigators will simultaneously examine the effects of FBI compared to stretching among PwMS in a lab-based setting Study 1 and home-based setting Study 2 Study 1 and 2 will run in parallel ie all data collection analysis and dissemination activities will occur simultaneously For both studies the investigators first postulate that a Functional Balance Intervention FBI can result in immediate improvements in physical function possibly mediated via improvements in secondary endpoints of dual-task balance functional mobility and gait Secondly the investigators postulate the possibility that cognition shares more similar neural processes with balance control than with other functional domains such that CNS adaptations induced by functional balance training could translate into immediate in cognition40 The improvements in physical and cognitive function will mediate improvements in other measures of daily living
Below are the combined specific aims for Study 1 and 2
Aim 1 Examine the effect of the FBI Intervention Group on physical function in PwMS compared to a stretching program Control Group
Hypothesis 1 After 4 months of training the FBI will show significantly higher improvements in physical function compared to the stretching
Aim 2 Examine the effect of a multicomponent FBI on cognitive function compared to PwMS in the stretching program
Hypothesis 2 After 4 months of training the FBI will show significantly higher improvements in cognitive function compared to the stretching
Aim 3 Examine the effects of the multicomponent FBI compared to the control group among PwMS on measures of daily living dual task performance balance confidence community mobility and quality of life
Hypothesis 3 After 4 months of training the FBI will show significantly higher improvements in measures of daily living compared to stretching
30 Research Design Both sub-studies included in this project ie Study 1 and 2 involve a randomized controlled trial design to establish the feasibility and initial effect of a multicomponent Functional Balance Intervention FBI for immediate improvements in physical and cognitive function and measures of daily living among persons with multiple sclerosis PwMS Study 1 will include training sessions in the lab and Study 2 will include training sessions at home Data collection procedures for Study 1 and 2 will run in parallel
A total sample of 120 participants with Multiple Sclerosis 60 in each study will be enrolled in this project The investigators expect 20 in-person screening failures Hence the investigators expect that 96 PwMS will be eligible to be included in the study undergo pre-training assessment and then randomized into 2 groups The Interventional Group n24 for Study 1 and n24 for Study 2 will undergo a multi component Functional Balance Intervention for 4 months whereas in the Control Group n24 for Study 1 and n24 for Study 2 will receive a stretching intervention for 4 months
Study overview Study 1 and 2 All participants will undergo the following procedures
Week 1 Recruitment and phone screening
Week 2 In-person screening 2 hours
Week 3 Pre-training assessment 2 hours
Week 4 Random Assignment
Week 5-20 Training sessions 1 hourday 2 times per week for 4 months
Week 21 Post-training assessment 2 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None