Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis

University of Erlangen-Nürnberg62 enrolled

Overview

The aim of the study is to evaluate the effects of a 12-week internet-based exercise and physical activity promotion intervention on physical activity. Furthermore, effects on symptoms of Multiple Sclerosis, Physical Activity-related Health Competence (PAHCO), self-concordance and basic needs satisfaction as well as usability and acceptability of the intervention will be investigated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Physical activity promotionBEHAVIORAL

Physical activity promotion activities consist of two phone or video calls with a therapists, two group video calls with a therapist, a complementary e-learning course and a fitness tracker that was provided.

ExerciseBEHAVIORAL

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 persons with MS. However, they can be adjusted according to participants prior physical activity level and their time for exercise during the week.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * basic computer and internet skills (e. g. using web browser and webcams) * ability to operate a smartphone (especially to install mobile applications) * ability to read, write and comprehend as well as communicate electronically Exclusion Criteria: * regularly physically active (more than 30 minutes twice a week with at least 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.) * clinically relevant cardiovascular diseases * cortisone therapy in the last 30 days * cognitive impairment that hampers study implementation * 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

Locations (9)

Neurological Rehabilitation Center Quellenhof

Bad Wildbad, Germany

Friedrich-Alexander University Erlangen-Nürnberg

Erlangen, Germany

Kliniken Schmieder Konstanz

Konstanz, Germany

Outcomes

Primary Outcomes

Changes in objectively measures physical activity

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.

Time frame: Baseline, after 3 months, after 6 months

Secondary Outcomes

Changes in subjectively measured physical activity: BSA-Questionnaire

The questionnaire asks for physical activities during a typical week. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report frequency and duration of activities executed during the last two weeks. Minutes of leisure-time physical activity per week and sport-/exercise related activity per week are calculated to get the physical activity and the sports score. Both scores can combined in order to receive the overall volume of physical activity completed during leisure-time and transportation as well as sport-/exercise-related activities.

Time frame: Baseline, after 3 months, after 6 months

Würzburger Fatigue Inventory for MS (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.

Time frame: Baseline, after 3 months, after 6 months

Allgemeine Depressionsskala (ADS-L)

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.

Time frame: Baseline, after 3 months, after 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Facharztpraxis für Neurologie und Psychiatrie Dr. med Wolfgang Mattes und Andreas Stockert

Fachklinik für Neurologie Dietenbronn GmbH

Schwendi, Germany

E/M/S/A - Zentrum für Neurologie/Psychiatrie/Neuroradiologie

Singen, Germany

Klinikum Stuttgart Katharinenhospital

Stuttgart, Germany

Neurologisch-Psychiatrische Praxis Dr. Weber

Stuttgart, Germany

Klinikum Würzburg Mitte gGmbH

Würzburg, Germany

Multiple Sclerosis Walking Scale-12

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).

Time frame: Baseline, after 3 months, after 6 months

Multiple Sclerosis Impact Scale (MSIS-29)

An disease-specific questionnaire that measures quality of life and limitations due tu multiple sclerosis on two subscales (physical impact of MS, 20 items; psychological impact of MS, 9 items).Scores for both scales are generated by summing individual item scores and transforming the sum to a 0-100 scale. Higher scores represent worse health.

Time frame: Baseline, after 3 months, after 6 months

Timed 25-Foot Walk Test (T25FW)

The task is to walk a 25foot distance as fast as possible. This test measures the functionality of the lower extremity and the walking speed.

Time frame: Baseline, after 3 months, after 6 months

Two-minute Walk Test (2MWT)

The 2MWT measures walking endurance. It measures walking distance over 2 minutes. The subject is asked to walk as far as possible in 2 minutes.

Time frame: Baseline, after 3 months, after 6 months

Selbstkonkordanz-Skala (SSK-Scale)

The SSK-Scale measures self-rated physical activity-related and sports-related self-concordance. It contains 12 items which are assigned to 4 subscales: intrinsic, identified, introjected and extrinsic Motivation. An overall score can be calculated based on these four subscales (minimal score = -10, maximal Score = +10). To receive the overall score the scores of the subscales for introjected and extrinsic motivation will be subtracted from the sum of the identified and intrinsic motivation subscales. A high total score suggest a high level of physical activity-related and sports-related self-concordance.

Time frame: Baseline, after 3 months, after 6 months

Physical activity-related health competence questionnaire

44-item questionnaire that measures physical activity-related health competence. The physical activity related health competence consists of three subcompetencies: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), PA-related self-regulation competence (14 items; min = 0, max = 14.8).

Time frame: Baseline, after 3 months, after 6 months

German psychological need satisfaction in exercise scale

This is a questionnaire to estimate the satisfaction of the three basic psychological needs based on self-determination theory during sports- and exercise related activities. It consists of 11 items which are assigned to 3 scales (one for each psychological need). Higher values on the scales indicate a higher needs satisfaction.

Time frame: Baseline, after 3 months, after 6 months

Usability and usefulness of the mobile application (meCue 2.0 questionnaire)

The module usability and usefulness of the meCue 2.0 questionnaire was used. The module contains 3 items on usability and 3 items on usefulness that are answered on a 7-point Likert scale (scored from 1 to 7). In order two receive a score for usability and a score for usefulness, the mean is calculated for the items of each area.

Time frame: after 3 months, after 6 months

Usability and usefulness of the intervention

Questionnaire including the Net Promoter Score and 45 self-developed items. Self-developed items covered willingness to pay, goal attainment, effects on physical function and wellbeing, adequacy of exercise prescription, evaluation of communication within the program, learning modules, App functions and activity trackers.

Time frame: after 3 months, after 6 months