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Effect of combined training exercises on fatigue and gait pattern in persons with relapsing-remitting multiple sclerosis

Evaluating the effects of a 12-week combined training program incorporating mechanical devices on fatigue, gait pattern, mood and health-related quality of life (HRQoL) in relapsing-remitting MS

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000449538
Enrollment
60
Registered
2015-05-08
Start date
2013-03-05
Completion date
2014-04-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate if an 12-week combined training exercises program (standar exercises + mechanical devices: Balance Trainer or Whole Body Vibration) improve aspects related to fatigue, gait pattern, mood and health-related quality of life (HRQoL) in relapsing-remitting Multiple Sclerosis.

Interventions

The intervention has been designed based on the intensity, frequency and duration established in the last reviews and the hypothesis that the Whole Body Vibration (WBV) or Balance Trainer (BT) in addition to a standard exercises program can improve fatigue and gait pattern. The duration was twice a week, during twelve week (24 sessions in total). The duration of the interventions increased progressively from 60 to 100 minutes, reached at the sixth-eighth week The participants will be divide i

The intervention has been designed based on the intensity, frequency and duration established in the last reviews and the hypothesis that the Whole Body Vibration (WBV) or Balance Trainer (BT) in addition to a standard exercises program can improve fatigue and gait pattern. The duration was twice a week, during twelve week (24 sessions in total). The duration of the interventions increased progressively from 60 to 100 minutes, reached at the sixth-eighth week The participants will be divide in three groups: Whole Body Vibration group (WBVgroup), Balance Trainer group (BTgroup) and Control group (CTgroup), which was in a waiting list to receive treatment. In the first two groups the nature of the program will be the same: Standard Exercise Program - 5min Warm Up - 15-30min Aerobic Exercise: (e.g. stationary bike, treadmill walking, elliptical or brisk walking in a circular corridor of 150m) - 15-30min Circuit Exercises: body weight exercises, coordination and balance exercises ((e.g. squats, unilateral weight bearing, dual-task, walk in a straight line, pilates ball exercises) - 15min Stretching: major muscle groups - 5min Cool-down: relaxation and breathing There will be breaks between exercises and the exercise programme is progressive and tailored towards individual capabilities and preferences. Mode of administration: Circuit training, a group exercise program adapted for individuals, supervised by an neurologic physical therapist. 4 to 8 individuals per group. In addition to a standard exercises program Group A) Whole Body Vibration Group [Using a Zeptor med System (Fa. Scisens, Germany)] Amplitude: 3mm, Frecuency f: 6Hz +/- 1Hz/sec. 5 repetition X 1 min (1 min rest) Group B) Balance Trainer Group Balance training is mechanical device that provides a fall-safe balancing environment (Medica Medizintechnik GmbH, Hochdorf, Germany) in interaction with the computer in order to training balance. 15 minutes of Balance Trainer. Twice times / week. -60-100 minutes/session Group C) Control Group. (Waiting list/No treatment) Adherence to treatment is monitored by records of attendance and punctuality. Level of Assistance to sessions Excellent: 90% or more. Good: 75% - 90%. Medium: 50% - 75%. Poor: less than 50%. Self-perception of physical effort and level of satisfaction is monitored using a Likert-type scale self-designed for the trial.

Sponsors

Guillermo Izquierdo Ayuso
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Persons with clinically definite Multiple Sclerosis relapsing-remiting, and an Expanded Disability Status Scale Score (EDSS) between 0-4.5 2) Fatigue is one of the most disabling symptoms for their activities daily living performance, with the Fatigue Severity Scale (FSS) score greater than or equal to 4

Exclusion criteria

1) MS relapse during three month immediately prior to study onset, or during the study 2) cognitive impairment that would interfere with the participating in the study 3) co morbidity that prevents autonomous walking, standing or aerobic exercise, for example, to ride a stationary bicycle 4) pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026