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Completed

NCT Number: NCT04057066

Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)

This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).

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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

Primary location

Neurological Rehabilitation Center Quellenhof, Bad Wildbad, Baden-Wurttemberg, Germany

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About this study

Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity promotion for this target group is needed. The internet is an attractive and feasible medium for physical activity promotion, however interventions have to be adapted to the special needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based exercise and physical activity counseling intervention.

26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and interviews will be conducted with participating pwMS to determine acceptability of the intervention and to explore participants experiences. Compliance with the intervention will be monitored. Additionally, changes in objective physical activity, subjective physical activity, fatigue, walking ability and level of depression will be calculated.

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)
  • expanded Disability Status Scale between 0 - 6.5
  • neurologically stable (no exacerbation within 30 days prior to enrollment)
  • internet access (WiFi)
  • basic knowledge on handling personal computer and the internet
  • owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
  • ability to read, write and comprehend as well as communicate electronically
  • not regularly physically active (more than 30 minutes twice a week with a moderate intensity (includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)

Exclusion criteria

  • clinically relevant cardiovascular diseases
  • cortisone therapy in the last 30 days
  • cognitive impairment
  • severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
  • severe internal, orthopaedic and metabolic diseases that restrict mobility

Treatment and study plan

Physical activity counseling

Behavioral

Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.

Exercise

Behavioral

Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.

Primary outcomes

  1. Acceptability of the Intervention and participants' experiences (focus groups)

    Time frame: 1 week after the end of the intervention

    Focus groups (1,5 hrs) with participants to determine extent to which they perceived intervention as appropriate.

  2. Compliance with intervention protocol (completed training sessions and e-learning modules)

    Time frame: over the 12 weeks of intervention

    Completed training sessions and e-learning modules will be documented for each participant with the interventions mobile app and e-learning course.

  3. Acceptability of the Intervention and participants' experiences (interviews)

    Time frame: 1 week after the end of the intervention

    With those participants that cannot take part in the focus groups, semistructured interviews (30 min) will be conducted to determine extent to which participants' perceived intervention as appropriate. Interview questions are based on focus group questions. The wording is slightly adapted to fit the interview situation.

Secondary outcomes

  1. Changes in objectively measures physical activity

    Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

    The physical activity level of participants is measured over a 7 day period with the accelerometer Actigraph GT3X+. The Actigraph GT3X+ measures acceleration on three axes. Steps per day, physical activity per day (activity counts) and time in moderate and vigorous physical activity per day will be calculated.

  2. Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)

    Time frame: 1 week before start of the intervention (T0), 1 week after end of the intervention (T1)

    8-item questionnaire to assess time spent for work related physical activity, physical activity for transportation (walking, biking), muscle strengthening exercises and sports, fitness or recreational physical activity during a typical week.

  3. Würzburger Fatigue Inventory for MS (WEIMuS)

    Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

    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.

  4. Allgemeine Depressionsskala (ADS-L)

    Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

    German version of the Center for Epidemiologic Studies Depression Scale, 20 item questionnaire. Each item is rated on a 4-point Likert scale. Answers are scored from 0 to 3. The scores for all items are added up to receive the total score. The total score ranges from 0 to 60 with higher scores representing higher levels of depression.

  5. Multiple Sclerosis Walking Scale-12

    Time frame: 1 week before start of the intervention (T0), 1 week after the end of the intervention (T1)

    12-item questionnaire measuring self reported walking ability. Each item is answered on a 5-point Likert scale. Answers are scored from 1 to 5. The scores for all items are added up to receive a total score. The total score ranges from 12 to 60 with higher scores representing higher levels of depression. As a last step the total score is transformed into the walk12-score ranging from 0 to 100 ((total score -12)/48 x 100 = walk12-score).

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg

Other

Collaborators

  • Aktion Multiple Sklerose Erkrankter, Landesverband der DMSG in Baden-Württemberg (AMSEL) e.V.
  • Klinikum Würzburg Mitte GmbH
  • Medi train - Zentrum für Gesundheitssport, Sport- und Physiotherapie
  • Neurological Rehabilitation Center Quellenhof
  • ZTM Bad Kissingen
  • motionNET systems Limited
  • proMX GmbH Nürnberg

Registry information

Official study title

Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis. A Feasibility Study.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2019
Registry last updated
Apr 27, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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