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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

126

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Matthias Mäurer, Dr., Caritas-Krankenhaus Bad Mergentheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • 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.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

4. maj 2016

Først indsendt, der opfyldte QC-kriterier

10. maj 2016

Først opslået (Skøn)

13. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

Studiedata/dokumenter

  1. Detailed intervention description
    Oplysningskommentarer: Detailed description of the processes of the e-training intervention (english language)
  2. Klinisk undersøgelsesrapport
    Oplysningskommentarer: Final report for funding foundation (german)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Multipel sclerose

  • City of Hope Medical Center
    National Cancer Institute (NCI)
    Aktiv, ikke rekrutterende
    Klassisk Hodgkin lymfom | Lymfocytrigt klassisk Hodgkin-lymfom | Ann Arbor Stage IB Hodgkin lymfom | Ann Arbor Stage II Hodgkin lymfom | Ann Arbor Stage IIA Hodgkin lymfom | Ann Arbor Stage IIB Hodgkin lymfom | Ann Arbor Stage I Hodgkin lymfom | Ann Arbor Stage I Mixed Cellularity Klassisk Hodgkin-lymfom og andre forhold
    Forenede Stater

Kliniske forsøg med e-training

3
Abonner