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PACE Study

Physical Activity in Gilenya-treated Patients with Multiple Sclerosis

Background

Physical training is a promising non-pharmacological approach to improving fatigue. Studies to date have shown the many positive effects of physical activity on physical fitness such as muscle strength, endurance and aspects of MS symptoms (e.g. ability to walk). However, the study situation regarding the effects of sport on fatigue is inconsistent. This is explained by the fact that fatigue has so far been surveyed predominantly as a secondary outcome, that the samples often did not show any fatigue and that the measuring instruments used were different.

To carefully assess the effect of exercise on fatigue in people with relapsing-remitting MS, pharmacological, disease-modifying therapy should also be considered as a consistent measure. Therefore, only people with MS who receive stable and efficient immunomodulatory treatment with Fingolimod are included in this study.

Aim of the study

This study examines the effect of structured physical exercise compared to a control group on the fatigue symptom of people with relapsing multiple sclerosis treated with Fingolimod (Gilenya®). Secondary outcomes are the dynamic muscle strength of the lower extremities, the isometric muscle strength of torso extensors such as flexors, health-related quality of life, depression, endurance performance (treadmill spiroergometry) and physical activity (accelerometry, Baecke questionnaire). The evaluation of the effect of the training program on the course of the disease and movement-related social-cognitive variables are explorative research objectives.

Methodology

Multi-centre, randomised, controlled study in parallel group design. Inclusion criteria: Persons with relapsing-remitting MS (according to the 2010 revised McDonald criteria), EDSS between 0 and 3.5, immunomodulatory treatment with Fingolimod for at least one month prior to baseline measurement, a fatigue score greater than or equal to 14 (measured with the Modified Fatigue Impact Scale) and neurologically stable with no signs of relapse within the last 30 days prior to inclusion day.

Participants are randomly allocated to the intervention group or the waiting control group. The allocation to these two groups takes place after the physical fitness level has been determined. The home-based training program is communicated via a web-based application (https://e-training.ms-intakt.de/) and can be individually adapted to the prerequisites and needs of the participants. The protocol focuses on a combined strength and endurance training and includes supplementary balance exercises. After the 6-month intervention phase, the intervention participants can train for a further 6 months and the participants of the waiting control group have the opportunity to take advantage of the training program for 6 months.

The primary outcome fatigue is measured with the Modified Fatigue Impact Scale (mFIS) before and immediately after the 6-month intervention. It is defined as the change (decrease) of the mFIS score immediately after the 6-month training phase compared to the baseline measurement.

Project duration: 01.11.2011-31.10.2014
Project managers: Prof. Dr. Mathias Mäurer, Caritas Krankenhaus, Bad Mergentheim; Prof. Dr. Klaus Pfeifer
Project staff: Christian Hentschke, Rene Streber, Dr. Alexander Tallner
Cooperation partners: 33 Neurological Clinics
Sponsor: Novartis Pharma GmbH (Contact: Frau Sabine Seibert)