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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)

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ClinicalTrials.gov Identifier: NCT02771652
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : June 24, 2016
Sponsor:
Collaborator:
Caritas-Krankenhaus Bad Mergentheim
Information provided by (Responsible Party):
Prof. Dr. Klaus Pfeifer, Friedrich-Alexander-Universität Erlange-Nürnberg

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: e-training Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: e-training intervention
Resistance and endurance training
Behavioral: e-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.

Control
no exercise
Other: Control
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 Measures :
  1. Change in Hamburg Quality of Life Questionnaire for Multiple Sclerosis (HAQUAMS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Würzburg Fatigue Scale (WEIMuS) [ Time Frame: 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.

  2. Muscle strength lower extremities [ Time Frame: 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).

  3. Forced vital capacity [ Time Frame: 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).

  4. Aerobic capacity [ Time Frame: 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.

  5. Physical activity [ Time Frame: 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.

  6. Peak expiratory flow [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771652


Sponsors and Collaborators
University of Erlangen-Nürnberg
Caritas-Krankenhaus Bad Mergentheim
Investigators
Principal Investigator: Matthias Mäurer, Dr. Caritas-Krankenhaus Bad Mergentheim

Additional Information:
Study Data/Documents: Detailed intervention description  This link exits the ClinicalTrials.gov site
Detailed description of the processes of the e-training intervention (english language)
Clinical Study Report  This link exits the ClinicalTrials.gov site
Final report for funding foundation (german)

Publications:
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.

Responsible Party: Prof. Dr. Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-Universität Erlange-Nürnberg
ClinicalTrials.gov Identifier: NCT02771652     History of Changes
Other Study ID Numbers: 1.01.1/09/007
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Prof. Dr. Klaus Pfeifer, Friedrich-Alexander-Universität Erlange-Nürnberg:
Multiple Sclerosis
Quality of Life
exercise
internet

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases