An interventional study of Circuit Training and Usual Care in Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 52 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Structured intervention to improve aerobic capacity, balance and strength
Other: Circuit Training
Unstructured intervention to improve mobility and balance
Other: Usual Care
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.
Exercises aimed at improving mobility and balance
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.
Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
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.
Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
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.
Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Change from Baseline 10 Meter Walking Test at 6-8 weeks
Assesses walking speed over a short distance
Time frame: 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
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)
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.
Time frame: 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
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)
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus