Multiple Sclerosis Clinical Trial
Official title:
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.
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; |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Don Carlo Gnocchi Onlus | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus |
Italy,
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) |
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