- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03271125
Intensive Multimodal Training for Persons With MS (Treadmill)
Intensive Multimodal Training for Persons With Multiple Sclerosis: Random Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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MI
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Milan, MI, Italien, 20148
- Fondazione don Carlo Gnocchi IRCCS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Treadmill group
Participants in the experimental group received supervised treadmill training
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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.
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Aktiv komparator: Resistance group
Participants in the control group were treated with Resistance exercises.
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Two minute walking test
Tidsramme: Two minutes
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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.
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Two minutes
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Timed up and go test
Tidsramme: 1 minute
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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.
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1 minute
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The Frontal Assessment Battery
Tidsramme: 10 minutes
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The Frontal Assessment Battery (FAB) is a short cognitive and behavioral six-subtest battery for the bedside screening of a global executive dysfunction.
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10 minutes
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Ten meter walking test
Tidsramme: 2 minutes
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The 10 meters walking test (10MWT) is a test in which the participant is timed while walking 10m at their comfortable speed.
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2 minutes
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The Berg Balance Scale
Tidsramme: 15 minutes
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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.
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15 minutes
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Dynamic Gait Index
Tidsramme: 15 minutes
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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.
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15 minutes
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The Short Form-12 questionnaire (SF-12)
Tidsramme: 10 minutes
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The SF12 is comprised of two domains, physical and mental and gives two composite scores that reflect the perceived health of the participant.
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10 minutes
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Treadmill MS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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