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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Circuit Training; Other: Usual Care

• Registration Number: NCT04006613
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circuit Training	Circuit Training	Structured intervention to improve aerobic capacity, balance and strength
Usual Care	Usual Care	Unstructured intervention to improve mobility and balance

Primary Outcome Measures

Name	Time	Method
Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline 10 Meter Walking Test at 6-8 weeks	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	Assesses walking speed over a short distance
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)	Is used to quantify functional lower limb strength. Time taken to stand up and sit down for 5 consecutive times.
Change from Baseline Hospital Anxiety and Depression Scale at 6-8 weeks	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	A two dimension scale to identify depression and anxiety. 14 items divided inti two 7 items subscales. The respondent rates each item on a 4 point scale (ranging from 0 to 3).Higher scores indicates greater anxiety and/or depression.
Change from Baseline Modified Dynamic Gait Index at 6-8 weeks	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	Assesses individual's ability to modify balance while walking during 8 specific tasks. Scoring system for each task is based on 3 aspects of walking performance: time to complete (min 0, max 3 points), gait pattern (min 0, max 3 points) and level of assistance (min 0, max 2 points). Total score ranges from 0 to 64 with greater scores indicating better performance.
Change from Baseline 6 Minutes Walking Test at 6-8 weeks	Baseline and at 6-8 weeks (after the completion of 16 training sessions)	Assesses distance walked over 6 minutes as a sub-maximal test of endurance capacity.
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)	Is a self report measure of the impact of MS on walking ability. The scoring gives a 1 (no limitation) to 5 (extreme limitation) option for each item.

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi Onlus; 🇮🇹 Milan, Italy