Effect of Aerobic Training vs Balance Training on Fatigue Symptom in Multiple Sclerosis Patient (FATI-gate)

Summary

Fatigue and impaired balance frequently affect patients with Multiple Sclerosis (MS). This is an open, prospective randomised crossover trial aimed at clarifying whether an improvement in balance control after balance training would also improve fatigue in patients with MS. Balance training will be compared to aerobic training, which is known to be effective on fatigue.

Conditions

• Multiple Sclerosis

Interventions

OTHER

Aerobic training

Aerobic training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Sessions will be performed with the assistance or supervision of a physical therapist and will consist of the following steps: 1) warm up with a stationary bike (no load, 10 min, 60 cycles/min); 2) upper and lower limb stretching (10 min); 3) 10 min rest in a sitting position; 4) first exercise bout: stationary bike, 15 min, 60 cycles/min (the load will be modulated so that the participant's heart rate is between 60 and 70% of the estimated maximum heart rate, and the patient perceives moderate fatigue on the Borg Rating of Perceived Exertion; 5) upper and lower limb stretching (10 min); 6) 10 min rest in a sitting position; 7) second exercise bout (same parameters as the first exercise bout); 8) upper and lower limb stretching (10 min).

OTHER

Balance training

Balance training: 15 daily sessions (5 sessions per week), each lasting approximately 90 minutes. Treatments will be performed with a physical therapist and will consist of the following exercises: 1) standing with feet together, 2) standing with closed eyes, 3) standing on unstable surfaces, 4) standing while performing upper limbs movements; 5) standing while performing head rotations; 6) walking on a treadmill at alternating speeds; 7) leg press and chest press exercises for training trunk balance during ballistic movements of the upper and lower limbs. These constituents of balance training can be combined in the same task according to the participant's ability.

Sponsors & Collaborators

• Istituto Auxologico Italiano

  lead OTHER

Principal Investigators

• Laura Perucca, MD · Istituto Auxologico Italiano

• Antonio Caronni, MD · Istituto Auxologico Italiano

• Stefano Scarano, MD · Istituto Auxologico Italiano

• Antonio Robecchi Majnardi, MD · Istituto Auxologico Italiano

• Giovanna Russo, MD · Istituto Auxologico Italiano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-17

Primary Completion

2019-11-30

Completion

2019-12-30