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Intensive Multimodal Training for Persons With MS (Treadmill)

31 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

42

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Two minute walking test
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Frontal Assessment Battery
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 gennaio 2013

Completamento primario (Effettivo)

19 maggio 2015

Date di iscrizione allo studio

Primo inviato

31 agosto 2017

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2017

Primo Inserito (Effettivo)

1 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 settembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Treadmill MS

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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