NCT01490840

Effect of Physical ACtivity in Fingolimod Treated patiEnts (PACE) With Relapsing-remitting Multiple Sclerosis

A 6-month, Multicenter, Randomized, Controlled Parallel Group Study to Evaluate the Effect of Physical Training on Fatigue in Patients With Relapsing-remitting Multiple Sclerosis Treated With Fingolimod, Followed by a 6 Month Optional Extension Phase

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effect of an individualized web-based physical training in fingolimod -treated patients.

Detailed description

In this study, it was planned to randomize 226 participants. However, only 178 participants were randomized during a timeframe of 2 years and 8 months. Therefore, the study was terminated due to slow enrollment and low participant compliance to the physical training schedule.

Conditions

• Fatigue in Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Physical exercise	Strength training exercises are performed against own body weight or with training aids like elastic rubber bands or gym balls. All exercises are home-based. To increase balance and core stability, a subset of exercises is performed on shaky ground and/or one-legged. Exercise intensity, duration and frequency are individually assigned by a sports therapist. For each muscle group, a set of exercises of increasing difficulty allows for individual and progressive training adaption. Therapists can choose from an exercise database of approximately 150 different strength exercises with different graduation.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-12-13
• Last updated: 2016-05-12
• Results posted: 2016-05-12

Locations

32 sites across 1 country: Germany