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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006613
• Other study ID #: CIRCUIT_SM
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Davide Cattaneo, PhD
• Phone: +390240308
• Email: dcattaneo[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• Usual Care
Exercises aimed at improving mobility and balance

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi Onlus	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)