Clinical trial NCT04006613: Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis
Official title: Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Fatigue
Balance
Aerobic training
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effects of a circuit training rehabilitation program on the perceived impact of fatigue in daily life situations and on gait and balance. Half of the participants will follow the circuit training program, while the other half will follow usual care rehabilitation programs.

Detailed description: Approximately 80% of Persons with Multiple Sclerosis rates fatigue among the three most disabling symptoms. Aerobic, balance and strength training have already been proved effective in rehabilitation, especially for Persons with Multiple Sclerosis. Fifty-two Persons with Multiple Sclerosis will be randomly allocated to an experimental group or to a control group following usual care rehabilitation programs. Experimental group will follow a circuit training rehabilitation program which combines high intensity aerobic training with balance and strength training. The study aims to verify the effects of the circuit training program on fatigue and on balance in different contexts with respect to usual care rehabilitation programs and to investigate effects of rehabilitation on immunological markers.

Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of Multiple Sclerosis (Polman criteria);
* No relapses in the previous three months;
* Expanded Disability Status Scale \< 6,5;
* Able to walk 20 meter with or without an assistive device;
* Able to stand for 30 second without aid;
* MiniMental State Examination \>20;

Exclusion Criteria:

* Unable to understand the aim of the study or unable to sign the informed consent form;
* Subjects following a steroidal drug therapy or assuming drugs affecting cardiac function;
* Subjects with psychiatric disorders;
* Subjects with cardiovascular diseases for whom aerobic training is forbidden;

Primary outcomes:
measure: Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Secondary outcomes:
measure: Change from Baseline Modified Dynamic Gait Index at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Change from Baseline 6 Minutes Walking Test at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Change from Baseline 10 Meter Walking Test at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Change from Baseline 5-Time-Sit-To-Stand at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Change from Baseline 12 item Multiple Sclerosis Walking Scale at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
measure: Change from Baseline Hospital Anxiety and Depression Scale at 6-8 weeks
timeFrame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione Don Carlo Gnocchi Onlus
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Davide Cattaneo, PhD
role: STUDY_DIRECTOR
References: