- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02771652
Effect of an Internet-based At-home Physical Training Protocol on Quality of Life, Fatigue, Functional Performance, Aerobic Capacity and Muscle Strength in Multiple Sclerosis Patients (ms-intakt)
23. juni 2016 oppdatert av: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
In this randomised controlled trial, the feasibility and effectiveness of an internet-based exercise intervention including progressive strength and endurance training (e-training) for PwMS was investigated.
Primary outcome was health-related quality of life, secondary outcomes were muscle strength, aerobic capacity and lung function, physical activity and fatigue.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
126
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- diagnosed Multiple Sclerosis (McDonald criteria),
- an EDSS score of less than or equal to 4.0,
- not less than 4 weeks of clinical stability prior to inclusion in the study,
- access to the internet.
- the taking of immunotherapeutic agents was not relevant and not monitored
Exclusion Criteria:
- primary progressive multiple sclerosis
- clinically relevant internal disease, especially cardiovascular or pulmonary disease, metabolic and orthopedic diseases
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: e-training intervention
Resistance and endurance training
|
The e-training intervention is a home-based aerobic and resistance training program.
Resistance training was prescribed twice weekly for a period of 12 weeks.
No special equipment was necessary except an elastic exercise band or a large gymnastic ball.
In addition, endurance training was to be carried out once a week.
Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale.
The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels.
Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard).
The exercise training was home-based and supervised via the internet.
Participants continued exercise training for another 12 weeks after the 3month assessment.
|
Annen: Control
no exercise
|
After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour.
After waiting three months, they received the same e-training intervention as the intervention group had received from the start.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
Tidsramme: Assessments took place at baseline and at 3 months
|
38 items generate the subscales of fatigue/thinking, mobility of the lower/upper extremities, communication and mood.
The HAQUAMS total score is calculated from a mean of the subscales, providing a total score between 1 and 5. Higher scores in HAQUAMS indicate lower levels in HRQoL.
The primary outcome will be the change over time from baseline to month 3.
|
Assessments took place at baseline and at 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Würzburg Fatigue Scale (WEIMuS)
Tidsramme: Assessments took place at baseline, at 3 and 6 months
|
This questionnaire contains 17 items that form a physical and cognitive subscale.
The total score ranges from zero to a maximum of 68 points (maximum fatigue).
The cut-off value for the presence of fatigue is above 32.
|
Assessments took place at baseline, at 3 and 6 months
|
Muscle strength lower extremities
Tidsramme: Assessments took place at baseline and after 3 and 6 months
|
Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
Forced vital capacity
Tidsramme: Assessments took place at baseline and after 3 and 6 months
|
Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
Aerobic capacity
Tidsramme: Assessments took place at baseline and after 3 and 6 months
|
As a marker of endurance capacity, maximal oxygen uptake (VO2peak) was determined by the spiroergometry device Master Screen CPX on a bicycle ergometer (Sanabike 250F, MESA, Germany) at 70-80 revolutions per minute.
|
Assessments took place at baseline and after 3 and 6 months
|
Physical activity
Tidsramme: Assessments took place at baseline and after 3 and 6 months
|
Habitual physical activity was assessed with the German version of the Baecke Questionnaire including three activity indices (work, sport, leisure time PA).
There were limitations concerning content validity in all indices; therefore, the sport score of the sport index was used.
That score is the product of the intensity, duration and frequency of a participant's reported sports activities.
Higher scores indicate a higher level of PA.
|
Assessments took place at baseline and after 3 and 6 months
|
Peak expiratory flow
Tidsramme: Assessments took place at baseline and after 3 and 6 months
|
Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
|
Assessments took place at baseline and after 3 and 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Matthias Mäurer, Dr., Caritas-Krankenhaus Bad Mergentheim
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Tallner A, Tzschoppe R,Peters S, Mäurer M, Pfeifer K. Internetgestützte Bewegungsförderung bei Personen mit Multipler Sklerose. Neurologie und Rehabilitation 19(1): 35-46, 2013.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2010
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. november 2011
Datoer for studieregistrering
Først innsendt
4. mai 2016
Først innsendt som oppfylte QC-kriteriene
10. mai 2016
Først lagt ut (Anslag)
13. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. juni 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2016
Sist bekreftet
1. juni 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1.01.1/09/007
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
Studiedata/dokumenter
-
Detailed intervention description
Informasjonskommentarer: Detailed description of the processes of the e-training intervention (english language)
-
Klinisk studierapport
Informasjonskommentarer: Final report for funding foundation (german)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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