Multiple Sclerosis
Conditions
Keywords
Fatigue, Balance, Aerobic training
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.
Interventions
OTHERCircuit 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.
OTHERUsual Care
Exercises aimed at improving mobility and balance
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Modified Fatigue Impact Scale at 6-8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline 10 Meter Walking Test at 6-8 weeks | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | Assesses walking speed over a short distance |
| Change from Baseline Modified Dynamic Gait Index at 6-8 weeks | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | 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 5-Time-Sit-To-Stand at 6-8 weeks | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | 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 | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | 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 | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | 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. |
| Change from Baseline 6 Minutes Walking Test at 6-8 weeks | Baseline and at 6-8 weeks (after the completion of 16 training sessions) | Assesses distance walked over 6 minutes as a sub-maximal test of endurance capacity. |
Countries
Italy
Outcome results
None listed