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Intensive Multimodal Training for Persons With MS (Treadmill)

31 août 2017 mis à jour par: Fondazione Don Carlo Gnocchi Onlus

Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial

The aim of this study was to evaluate the safety, feasibility and preliminary effects of a high-intensity rehabilitative multimodal training protocol carried out on treadmill on walking efficacy, mobility, balance, executive function, fatigue and health-related quality of life in a sample of persons with moderate to severe MS deficit of mobility compared to a control group that received a strengthening program of similar intensity.

Aperçu de l'étude

Statut

Complété

Description détaillée

Persons with multiple sclerosis can have various deficits, affecting many aspects of physical and cognitive functioning often leading to low levels of physical activity in daily life. These include poor endurance, muscle weakness, incoordination and poor balance and cognitive deficits that can all lead to persistent mobility difficulties in daily life.

Given the importance of exercise and physical activity for persons with multiple sclerosis that are already moderately to severely hampered by their locomotor ability and balance, the setting up of intense functional mobility training that targets the main deficits, in adjunction to a clinical rehabilitation usual care and under close supervision, may be a viable way of increasing the level of physiological health and give a basis for the persons to start their own activity pursuit outside of the rehabilitation clinic. Treadmill walking has several benefits for mobility rehabilitation. First, it is a everyday task, walking. Second it lends itself well to a dual task paradigm where other aspects of mobility, such as equilibrium and cognitive factors can be addressed during walking. Third, even persons with severe walking limitations can train walking at various speeds when on treadmill, holding onto handrails and using safety harnesses that minimize the possibility of adverse events during training. Further, the treadmill paradigm lends itself well to training with progressive task difficulty, numerous rhythmic repetitions, and importantly it can include an aerobic component to improve cardiorespiratory fitness. All of which should lead to improved submaximal exercise tolerance and endurance, more functional mobility and consequently increased ability to carry out activities of daily living.

Methods: A consecutive sample of 42 People with Multiple Sclerosis (PwMS) were recruited from the outpatient/inpatient rehabilitation service of the Don Gnocchi Foundation. The study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of the Don Gnocchi Foundation. Subjects signed an informed consent form before the beginning of the study.

The study design was a two arm randomized 2:1 controlled trial (see study flow chart in Figure 1).

The participants were assessed before and after the rehabilitation period by researchers blinded to group assignment.

Participants in both groups received 15- 20 treatments sessions lasting 30 minutes 5 times per week by experienced physical therapists trained for the study. All participants also followed their usual rehabilitation care protocols as planned.

Type d'étude

Interventionnel

Inscription (Réel)

42

Phase

  • N'est pas applicable

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

    • MI
      • Milan, MI, Italie, 20148
        • Fondazione don Carlo Gnocchi IRCCS

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

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diagnosis of multiple sclerosis according to McDonald's criteria (Polman et al. Ann Neurology 2011)
  • EDSS score <= 7
  • Free from relapses and steroid treatment for at least 1 month)
  • Able to stand 30 seconds,
  • Able to walk at least 10 meters independently or with a cane
  • Able to understand and follow instructions
  • Stable neurological conditions and willingness to participate in the study.

Exclusion Criteria:

  • Cardiac pacemaker
  • Any pre-existing conditions that affected walking function
  • diagnosis of depression or psychotic disorder

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treadmill group
Participants in the experimental group received supervised treadmill training
Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
Comparateur actif: Resistance group
Participants in the control group were treated with Resistance exercises.
Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Two minute walking test
Délai: Two minutes
The subjects were instructed to walk at their usual speed for 2 minutes while the distance they covered in 2 minutes was recorded in meters.
Two minutes
Timed up and go test
Délai: 1 minute
The Timed Up & Go test (TUG) is a simple functional test that requires a person to stand up, walk 3m, turn back, and sit down again while being timed.
1 minute

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The Frontal Assessment Battery
Délai: 10 minutes
The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
10 minutes
Ten meter walking test
Délai: 2 minutes
The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
2 minutes
The Berg Balance Scale
Délai: 15 minutes
The Berg Balance Scale (BBS) is a 14-item scale widely used to assess balance disorders in PwMS. BBS provides information about patient's balance-related abilities.
15 minutes
Dynamic Gait Index
Délai: 15 minutes
The Dynamic Gait Index (DGI) measures gait function and dynamic balance. The eight tasks of this scale include walking, walking with head turns, pivoting, walking over objects, walking around objects, and going upstairs.
15 minutes
The Short Form-12 questionnaire (SF-12)
Délai: 10 minutes
The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
10 minutes

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette 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 (Réel)

8 janvier 2013

Achèvement primaire (Réel)

19 mai 2015

Dates d'inscription aux études

Première soumission

31 août 2017

Première soumission répondant aux critères de contrôle qualité

31 août 2017

Première publication (Réel)

1 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 septembre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

Due to ethical restrictions set by the Ethics Committee of Fondazione Don Carlo Gnocchi and the presence of identifying patient information, researchers wishing to access raw data for use in future research studies should write to the Corresponding Author that will apply to the Ethics Committee of Fondazione Don Carlo Gnocchi for approval. Additional data

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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 .

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