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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Circuit Training; Other: Usual Care

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Davide Cattaneo, PhD; Phone Number: 814 +390240308; Email: dcattaneo@dongnocchi.it

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Fondazione Don Carlo Gnocchi Onlus
    • Contact: Rita Bertoni, MSc; Phone Number: 814 +390240308; Email: rbertoni@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circuit Training; Structured intervention to improve aerobic capacity, balance and strength	Other: 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.
Active Comparator: Usual Care; Unstructured intervention to improve mobility and balance	Other: Usual Care; Exercises aimed at improving mobility and balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Modified Dynamic Gait Index at 6-8 weeks	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.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Change from Baseline 6 Minutes Walking Test at 6-8 weeks	Assesses distance walked over 6 minutes as a sub-maximal test of endurance capacity.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Change from Baseline 10 Meter Walking Test at 6-8 weeks	Assesses walking speed over a short distance	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	Is used to quantify functional lower limb strength. Time taken to stand up and sit down for 5 consecutive times.	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	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.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Change from Baseline Hospital Anxiety and Depression Scale at 6-8 weeks	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.	Baseline and at 6-8 weeks (after the completion of 16 training sessions)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Study Director: Davide Cattaneo, PhD, IRCCS Fondazione Don Carlo Gnocchi

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Balance; Fatigue; Aerobic training
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CIRCUIT_SM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No