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Clinical Trials/NCT04057066
NCT04057066
Completed
N/A

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

University of Erlangen-Nürnberg3 sites in 1 country26 target enrollmentFebruary 28, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Erlangen-Nürnberg
Enrollment
26
Locations
3
Primary Endpoint
Acceptability of the Intervention and participants' experiences (focus groups)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2019
End Date
August 16, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Klaus Pfeifer

Head of the Department of Sport Science and Sport

University of Erlangen-Nürnberg

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in objectively measures physical activity(1 week before start of the intervention (T0), 1 week after the end of the intervention (T1))
  • Changes in subjectively measured physical activity: European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ)(1 week before start of the intervention (T0), 1 week after end of the intervention (T1))
  • Würzburger Fatigue Inventory for MS (WEIMuS)(1 week before start of the intervention (T0), 1 week after the end of the intervention (T1))
  • Allgemeine Depressionsskala (ADS-L)(1 week before start of the intervention (T0), 1 week after the end of the intervention (T1))
  • Multiple Sclerosis Walking Scale-12(1 week before start of the intervention (T0), 1 week after the end of the intervention (T1))

Study Sites (3)

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