FlexToBa for People With Multiple Sclerosis
21. února 2017 aktualizováno: Edward McAuley, University of Illinois at Urbana-Champaign
Improving Functional Performance in Persons With MS Via Physical Activity DVD Intervention
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Persons with MS are less likely to be active than their healthy counterparts, a statistic that is compounded by the symptom manifestations of MS.
However, there is increasing evidence to support the importance of physical activity in MS.
Unfortunately, structured, safe, and efficacious physical activity programs that are often conducted in medical or university settings are often not accessible to many older adults with or without MS.
We propose to conduct a randomized controlled pilot trial testing the efficacy of a DVD-delivered physical activity intervention which targets factors that have the potential to reduce disability in older adults with MS.
This DVD-based intervention has been previously approved by the IRB at the University of Illinois for a similar study with low-active, community-dwelling older adults (IRB Protocol Number: 09765).
This novel intervention provides systematic, programmatic activities with alternative versions of each exercise that allow individuals of all capabilities to complete the program successfully.
It focuses on improving flexibility, strength, and balance and has been demonstrated to be feasible, well-accepted, and efficacious in a large sample of older adults without MS.
Importantly, intervention resulted in clinically significant improvements in the Short Physical Performance Battery, reliable determinant of disability, institutionalization, morbidity, and mortality.
If such an intervention was equally successful in older persons with MS, this could have considerable public health impact.
Typ studie
Intervenční
Zápis (Aktuální)
50
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Illinois
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Urbana, Illinois, Spojené státy, 61801
- University of Illinois at Urbana-Champaign
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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).
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Experimental: FlexToBa physical activity DVD
Participants in this arm will receive a physical activity program delivered by DVD that focuses on exercises targeting flexibility, toning and balance.
These exercises will be progressive in nature throughout the six months and will also focus on modifications for all ability levels.
Participants will be provided with three DVDs including: an Introduction to physical activity, Sessions 1-3, and Sessions 4-6, which they will be asked to watch and participate in over the course of six months.
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Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance.
Exercises will be progressive over the six-months and will highlight modifications for varying levels.
This program will be delivered on 3 DVDs.
Participants will be asked to exercise with the DVD at least three times per week.
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Aktivní komparátor: Usual care-Wait list
Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
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Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity.
They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have Multiple Sclerosis
Časové okno: Baseline and six months
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The measurements will include: Short physical performance battery -- measures walking speed, ability to rise from a chair, and standing balance |
Baseline and six months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Časové okno: Baseline and six-months
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Measurements will include: Timed 20-foot walk test -- walk 25 feet as quickly as possible; |
Baseline and six-months
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Change in assessments of functional fitness assessments in sedentary adults with MS
Časové okno: Baseline and six-months
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Measurements will include: 6-minute walk test -- walk as much as possible (in terms of distance) for 6 minutes; |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Časové okno: Baseline and six-months
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Measurements will include: Grip strength -- using a dynamometer, participants will demonstrate isometric grip strength; |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Časové okno: Baseline and six-months
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Measurements will include: Flexibility -- sit and reach (lower body flexibility) and back scratch test (upper body flexibility) |
Baseline and six-months
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Change from baseline to six-months in assessments of functional fitness of sedentary adults with MS
Časové okno: Baseline and six-months
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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
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Change from baseline to six-months in assessments of functional fitness of sedentary adults who have MS
Časové okno: Baseline and six-months
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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
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Change from baseline to six-months in assessments of reported quality of life in people with MS
Časové okno: Baseline and six months
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The Leeds Multiple Sclerosis Quality of Life Scale will be used as a disease specific quality of life measure for people with MS.
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Baseline and six months
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Change from baseline to six-months in assessments of reported quality of life in people with MS
Časové okno: Baseline and six-months
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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.
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Baseline and six-months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline to six-months in assessments of cognitive performance in sedentary adults with MS
Časové okno: Baseline and six months
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The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery, which will be administered to assess cognitive performance.
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Baseline and six months
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Change from baseline to six-months in assessments of reported barriers self-efficacy in people with MS
Časové okno: Baseline and six months
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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.
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Baseline and six months
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Changes in physical activity relating to specified exercise program in sedentary adults with MS
Časové okno: Baseline and six months
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Adherence to exercise program as documented by daily exercise logs.
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Baseline and six months
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Objective changes in physical activity in sedentary adults with MS
Časové okno: Baseline and six months
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Objective assessment of physical activity via accelerometry over seven days time.
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Baseline and six months
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Self-reported changes in physical activity in sedentary adults with MS
Časové okno: Baseline and six months
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Subjective assessment of physical activity via the Godin Leisure Time Exercise Questionnaire, which assesses frequency of involvement in strenuous, moderate and light activities.
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Baseline and six months
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Change from baseline to six-months in assessments of reported gait self-efficacy in sedentary adults with MS
Časové okno: Baseline and six-months
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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.
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Baseline and six-months
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Change from baseline to six-months in assessments of reported exercise self-efficacy in sedentary people with MS
Časové okno: Baseline and six-months
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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.
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Baseline and six-months
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Change from baseline to six-months in assessments of reported self-efficacy of walking in sedentary people with MS
Časové okno: Baseline and six-months
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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.
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Baseline and six-months
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Edward McAuley, PhD, University of Illinois at Urbana-Champaign
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2013
Primární dokončení (Aktuální)
1. září 2014
Dokončení studie (Aktuální)
1. září 2014
Termíny zápisu do studia
První předloženo
18. října 2013
První předloženo, které splnilo kritéria kontroly kvality
20. listopadu 2013
První zveřejněno (Odhad)
25. listopadu 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. února 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. února 2017
Naposledy ověřeno
1. února 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IL-0009
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
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