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Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior (FARMS-2)

23 novembre 2014 mis à jour par: University of Illinois at Urbana-Champaign
Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

Aperçu de l'étude

Description détaillée

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.

It is well known that causes of falls are multifactorial with over 400 risk factors identified. However, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. For instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in MS . Behavioral fall risk factors in MS include choosing appropriate footwear, lighting and utilizing appropriate assistive device. There is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with MS and have been shown to reduce fall risk and incidence in other clinical populations. This has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with MS. However, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with MS. This proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with MS.

Type d'étude

Interventionnel

Inscription (Réel)

37

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Illinois
      • Urbana, Illinois, États-Unis, 61802
        • University of Illinois UC

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Definite multiple sclerosis diagnosis
  • ambulatory
  • aged 50-75 years of age
  • fallen within 12 months

Exclusion Criteria:

  • non-ambulatory
  • outside age range
  • no fall history

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Home-based Exercise
Participants will be taught a series of exercises targeting balance and lower limb strength in four instructional sessions. They will be asked to complete exercises 3 times a week for 12 weeks. Exercise compliance will be recorded with a diary.
exercise to look at balance and lower limb strength record in diary
Expérimental: Education
Participants will attend 4 education sessions focusing on interaction of beliefs, behaviors and symptoms on falls. They will be taught self-management principles to modify their fall risk.
sessions to discuss self-management ideas to modify risk of falling
Expérimental: Exercise plus education
Participants will attend 2 instructional exercise sessions as well as 2 education sessions. Participants will be asked to complete exercises at home 3 times per week and engage in behavior to minimize fall risk.
combination of exercise sessions with education sessions to modify fall risk
Aucune intervention: Control
Participants will not receive any treatment.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Fall incidence
Délai: 3 months
3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physiological Fall Risk
Délai: 3 Months
Physiological fall risk will be determined by the short form of the Physiological Profile Assessment (PPA)(Lord, 2003). The PPA is a standardized test battery which assesses vision (edge contrast sensitivity), lower limb proprioception, strength (knee extension), postural sway, and cognitive function (simple hand reaction time). The outcome of each test will be combined to generate an overall fall risk score
3 Months
Mobility
Délai: 3 months
Specific measures of walking speed, endurance, coordination and self-reported walking function scale will be employed to assess overall mobility of each person. Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.
3 months
Balance
Délai: 3 Months
To assess balance (e.g. postural control), we conducted a clinical assessment To measure balance the Berg Balance Scale (BBS) and self-reports of balance confidence will be used. The BBS is a clinical assessment of balance. Scores on the BBS range from 0-56 with higher scores indicating greater balance. The Activities-Specific Balance Confidence (ABC) scale was used as a measure of balance confidence.
3 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Jacob Sosnoff, University of Illinois at Urbana-Champaign

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2013

Achèvement primaire (Réel)

1 septembre 2014

Achèvement de l'étude (Réel)

1 septembre 2014

Dates d'inscription aux études

Première soumission

17 avril 2013

Première soumission répondant aux critères de contrôle qualité

4 octobre 2013

Première publication (Estimation)

8 octobre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

25 novembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 novembre 2014

Dernière vérification

1 novembre 2014

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Home-based exercise

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