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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)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
e-training
Control
Sponsored by
University of Erlangen-Nürnberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Quality of Life, exercise, internet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    e-training intervention

    Control

    Arm Description

    Resistance and endurance training

    no exercise

    Outcomes

    Primary Outcome Measures

    Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
    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.

    Secondary Outcome Measures

    Würzburg Fatigue Scale (WEIMuS)
    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.
    Muscle strength lower extremities
    Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
    Forced vital capacity
    Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
    Aerobic capacity
    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.
    Physical activity
    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.
    Peak expiratory flow
    Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).

    Full Information

    First Posted
    May 4, 2016
    Last Updated
    June 23, 2016
    Sponsor
    University of Erlangen-Nürnberg
    Collaborators
    Caritas-Krankenhaus Bad Mergentheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02771652
    Brief Title
    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
    Acronym
    ms-intakt
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Erlangen-Nürnberg
    Collaborators
    Caritas-Krankenhaus Bad Mergentheim

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis
    Keywords
    Multiple Sclerosis, Quality of Life, exercise, internet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    e-training intervention
    Arm Type
    Active Comparator
    Arm Description
    Resistance and endurance training
    Arm Title
    Control
    Arm Type
    Other
    Arm Description
    no exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    e-training
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS)
    Description
    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.
    Time Frame
    Assessments took place at baseline and at 3 months
    Secondary Outcome Measure Information:
    Title
    Würzburg Fatigue Scale (WEIMuS)
    Description
    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.
    Time Frame
    Assessments took place at baseline, at 3 and 6 months
    Title
    Muscle strength lower extremities
    Description
    Maximum isometric muscle strength was tested with the M3 Diagnos machine (Schnell, Peutenhausen, Germany).
    Time Frame
    Assessments took place at baseline and after 3 and 6 months
    Title
    Forced vital capacity
    Description
    Forced vital capacity (FVC) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
    Time Frame
    Assessments took place at baseline and after 3 and 6 months
    Title
    Aerobic capacity
    Description
    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.
    Time Frame
    Assessments took place at baseline and after 3 and 6 months
    Title
    Physical activity
    Description
    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.
    Time Frame
    Assessments took place at baseline and after 3 and 6 months
    Title
    Peak expiratory flow
    Description
    Peak expiratory flow (PEF) was tested with the Master Screen CPX System (Viasys Healthcare, Cardinal Health, Germany).
    Time Frame
    Assessments took place at baseline and after 3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthias Mäurer, Dr.
    Organizational Affiliation
    Caritas-Krankenhaus Bad Mergentheim
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    http://www.zentrum-patientenschulung.de/manuale/schulung/index.php?schulungen_id=186
    Description
    certified as patient education program (german)
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Detailed intervention description
    Available IPD/Information URL
    https://www.sport.fau.de/files/2016/05/ms-intakt-e-training-intervention-description.pdf
    Available IPD/Information Comments
    Detailed description of the processes of the e-training intervention (english language)
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    https://www.sport.fau.de/files/2015/05/ms-intakt-abschlussbericht-19_05_2015.pdf
    Available IPD/Information Comments
    Final report for funding foundation (german)

    Learn more about this trial

    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

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