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Completed

NCT Number: 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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e-training

Behavioral

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

Other

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • Caritas-Krankenhaus Bad Mergentheim

Registry information

Acronym: ms-intakt

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 13, 2016
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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