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Completed

NCT Number: NCT04006613

Effects of a Circuit Training on Balance 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Circuit Training

Other

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 Care

Other

Exercises aimed at improving mobility and balance

Primary outcomes

  1. 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

  1. 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)

    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.

  2. 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)

    Assesses distance walked over 6 minutes as a sub-maximal test of endurance capacity.

  3. 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)

    Assesses walking speed over a short distance

  4. 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)

    Is used to quantify functional lower limb strength. Time taken to stand up and sit down for 5 consecutive times.

  5. 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)

    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.

  6. 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)

    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.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Effects of a Circuit Training on Balance Management in a State of Fatigue in Persons With Multiple Sclerosis

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2019
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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