Multiple SclerosisNCT04006613
Effects of a Circuit Training on Balance in Persons With Multiple Sclerosis
A study testing Circuit Training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Circuit Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2019to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Circuit Training, Usual Care
- Keywords
- Fatigue, Balance, Aerobic training
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit TrainingOther
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.
Usual CareOther
Exercises aimed at improving mobility and balance
| Study group | Role | What they receive |
|---|---|---|
| Circuit Training | Experimental | Structured intervention to improve aerobic capacity, balance and strength Receives: Other: Circuit Training |
| Usual Care | Active comparator | Unstructured intervention to improve mobility and balance Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start26 Feb 2019
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davide Cattaneo, PhD, Study director, IRCCS Fondazione Don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006613
- Sponsor's protocol ID
- CIRCUIT_SM
- Status last verified
- Jul 2025
- First submitted
- 29 May 2019
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04006613
- Acronym / sponsor ID
- CIRCUIT_SM
- Conditions
- Multiple Sclerosis
- Keywords
- Fatigue, Balance, Aerobic training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circuit Training | Experimental | Other: Circuit TrainingStructured intervention to improve aerobic capacity, balance and strength |
| Usual Care | Active comparator | Other: Usual CareUnstructured intervention to improve mobility and balance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit Training20 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. | Other | Circuit Training |
| Usual CareExercises aimed at improving mobility and balance | Other | Usual Care |
Primary outcome
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.
6 secondary outcomes
Change from Baseline Modified Dynamic Gait Index at 6-8 weeks
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
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
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
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
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
Time frame: Baseline and at 6-8 weeks (after the completion of 16 training sessions)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Cattaneo, PhD study director
IRCCS Fondazione Don Carlo Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit Training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.