Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT04057066|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Physical activity counseling Behavioral: Exercise||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis|
|Actual Study Start Date :||February 28, 2019|
|Estimated Primary Completion Date :||August 20, 2019|
|Estimated Study Completion Date :||August 20, 2019|
Participants receive physical activity counseling as well as an individualized exercise plan.
Behavioral: Physical activity counseling
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
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): NCT04057066
|Neurological Rehabilitation Center Quellenhof|
|Bad Wildbad, Baden-Wuerttemberg, Germany, 75323|
|Klinikum Würzburg Mitte gGmbH|
|Würzburg, Bavaria, Germany, 97070|
|Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU)|
|Principal Investigator:||Klaus Pfeifer, Prof. Dr.||Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Sport Science and Sport|
|Principal Investigator:||Peter Flachenecker, Prof. Dr. med.||Neurological Rehabilitation Center Quellenhof|
|Principal Investigator:||Mathias Mäurer, Prof. Dr. med.||Klinikum Würzburg Mitte gGmbH|