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

NCT04006613 | Completed

• 1 other identifier: CIRCUIT_SM
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Fatigue; Balance; Aerobic training

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks

  Provides an assessment of the effects of fatigue in terms of physical, cognitive and psychosocial functioning. Participant rates on a 5 point Likert scale (from 0="never" to 4= "Almost Always") their agreement with 21 statements. Higher numbers indicate greater fatigue.

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

Secondary Outcomes (6)

• Change from Baseline Modified Dynamic Gait Index at 6-8 weeks

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

• Change from Baseline 6 Minutes Walking Test at 6-8 weeks

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

• Change from Baseline 10 Meter Walking Test at 6-8 weeks

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

• Change from Baseline 5-Time-Sit-To-Stand at 6-8 weeks

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

• Change from Baseline 12 item Multiple Sclerosis Walking Scale at 6-8 weeks

  Baseline and at 6-8 weeks (after the completion of 16 training sessions)

Study Arms (2)

Circuit Training

EXPERIMENTAL

Structured intervention to improve aerobic capacity, balance and strength

Other: Circuit Training

Usual Care

ACTIVE COMPARATOR

Unstructured intervention to improve mobility and balance

Other: Usual Care

Interventions

Circuit Training 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.

Circuit Training

Usual Care OTHER

Exercises aimed at improving mobility and balance

Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Davide Cattaneo, PhD

  IRCCS Fondazione Don Carlo Gnocchi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: July 5, 2019
• Study Start: February 26, 2019
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IT (1)