Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis

NCT ID: NCT04006613

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2025-05-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Circuit Training

Structured intervention to improve aerobic capacity, balance and strength

Group Type EXPERIMENTAL

Circuit Training

Intervention Type OTHER

20 minutes of High Intensity Aerobic Training (HI) on treadmill: 2 minutes warm up + 4x 4 minutes HI+ 2 minutes of active recovery; 10 minutes of dynamic balance training; 10 minutes of functional strength training.

Usual Care

Unstructured intervention to improve mobility and balance

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Exercises aimed at improving mobility and balance

Interventions

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Circuit Training

20 minutes of High Intensity Aerobic Training (HI) on treadmill: 2 minutes warm up + 4x 4 minutes HI+ 2 minutes of active recovery; 10 minutes of dynamic balance training; 10 minutes of functional strength training.

Intervention Type OTHER

Usual Care

Exercises aimed at improving mobility and balance

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Cattaneo, PhD

Role: STUDY_DIRECTOR

IRCCS Fondazione Don Carlo Gnocchi

Locations

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Fondazione Don Carlo Gnocchi Onlus

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CIRCUIT_SM

Identifier Type: -

Identifier Source: org_study_id

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