Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
Circuit Training
Structured intervention to improve aerobic capacity, balance and strength
Intervention: Circuit Training (Other)
Usual Care
Unstructured intervention to improve mobility and balance
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks
Time Frame: 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 Outcomes
- Change from Baseline 10 Meter Walking Test at 6-8 weeks(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(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(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline Modified Dynamic Gait Index at 6-8 weeks(Baseline and at 6-8 weeks (after the completion of 16 training sessions))
- Change from Baseline 6 Minutes Walking Test at 6-8 weeks(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(Baseline and at 6-8 weeks (after the completion of 16 training sessions))