Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Circuit Training
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Fatigue, Balance, Aerobic training
Eligibility Criteria
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;
Sites / Locations
- Fondazione Don Carlo Gnocchi OnlusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Circuit Training
Usual Care
Arm Description
Structured intervention to improve aerobic capacity, balance and strength
Unstructured intervention to improve mobility and balance
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change from Baseline 10 Meter Walking Test at 6-8 weeks
Assesses walking speed over a short distance
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.
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.
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.
Full Information
NCT ID
NCT04006613
First Posted
May 29, 2019
Last Updated
September 11, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT04006613
Brief Title
Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis
Official Title
Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Fatigue, Balance, Aerobic training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circuit Training
Arm Type
Experimental
Arm Description
Structured intervention to improve aerobic capacity, balance and strength
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Unstructured intervention to improve mobility and balance
Intervention Type
Other
Intervention Name(s)
Circuit Training
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
Exercises aimed at improving mobility and balance
Primary Outcome Measure Information:
Title
Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
Description
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.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Secondary Outcome Measure Information:
Title
Change from Baseline Modified Dynamic Gait Index at 6-8 weeks
Description
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.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Title
Change from Baseline 6 Minutes Walking Test at 6-8 weeks
Description
Assesses distance walked over 6 minutes as a sub-maximal test of endurance capacity.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Title
Change from Baseline 10 Meter Walking Test at 6-8 weeks
Description
Assesses walking speed over a short distance
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Title
Change from Baseline 5-Time-Sit-To-Stand at 6-8 weeks
Description
Is used to quantify functional lower limb strength. Time taken to stand up and sit down for 5 consecutive times.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Title
Change from Baseline 12 item Multiple Sclerosis Walking Scale at 6-8 weeks
Description
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.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Title
Change from Baseline Hospital Anxiety and Depression Scale at 6-8 weeks
Description
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.
Time Frame
Baseline and at 6-8 weeks (after the completion of 16 training sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Cattaneo, PhD
Phone
+390240308
Ext
814
Email
dcattaneo@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Cattaneo, PhD
Organizational Affiliation
IRCCS Fondazione Don Carlo Gnocchi
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi Onlus
City
Milan
ZIP/Postal Code
20148
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rita Bertoni, MSc
Phone
+390240308
Ext
814
Email
rbertoni@dongnocchi.it
12. IPD Sharing Statement
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Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis
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