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Trial registered on ANZCTR


Registration number
ACTRN12615000449538
Ethics application status
Approved
Date submitted
12/03/2015
Date registered
8/05/2015
Date last updated
8/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of combined training exercises on fatigue and gait pattern in persons with relapsing-remitting multiple sclerosis
Scientific title
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
Secondary ID [1] 286324 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 294422 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294732 294732 0 0
Physiotherapy
Neurological 294777 294777 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291366 0
Rehabilitation
Comparator / control treatment
Group C) Control Group. (Waiting list/No treatment).
The control group will be offered a standard exercise program that includes Whole Body Vibrations, after twelve weeks.
Control group
Active

Outcomes
Primary outcome [1] 294496 0
Fatigue.

Measured by FSS: (Fatigue Severity Scale)


Timepoint [1] 294496 0
Baseline and 12 weeks after intervention commencement
Primary outcome [2] 294810 0
Fatigue.
Measured by MFIS: (Modified Fatigue Impact Scale). Divided in:
MFIS physical
MFIS cognitive
MFIS phychosocial
Timepoint [2] 294810 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [1] 313461 0
Mood:

BDI: (Beck Depression Inventory)

Timepoint [1] 313461 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [2] 314112 0
Gait analysis

We examine gait with GAITRite™ electronic walkway, is a portable gait analysis system and is activated by mechanical pressure as the subject walks on it.

The gait parameters include in the analysis are: FAP, velocity (cm/sec), cadence (steps/min), step time (s), base of support (cm), swing phase and double support (% gait cycle) and step length difference (cm)
Timepoint [2] 314112 0
Baseline and 12 weeks after intervention commencement
Secondary outcome [3] 314113 0
Health Related Quality of Life:

MusiQoL Questionnaire
Timepoint [3] 314113 0
Baseline and 12 weeks after intervention commencement

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are recruited from MS Units in Hospital University Virgen Macarena (Seville, Spain)


- 1st visit: physician generates a EDSS, potential participants are derive to neurologic physical therapist.


- 2nd visit: Neurological physical therapist, as a blinded assessor, perform baseline assessment. Demographic data are collected, participants complete self-reported measures (FSS, MFIS, BDI and MusiQoL) and gait analysis is performed with GAITRite™


- 3rd visit: Concealed allocation and randomization.

Subject who meet the inclusion criteria will be randomly assigned to one of three groups using a random numbers table by the physiotherapist who also conduct the intervention. Therefore, the blinded assessor doesn´t know which group each subject belongs.

Method of allocation concealment: central randomisation by computer


- Intervention. Two physical therapist during 12 weeks


- Final assessment by the blinded assessor following the same protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants who meet the inclusion criteria are randomly assigned to one of three groups using a random numbers table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6720 0
Spain
State/province [1] 6720 0
Seville

Funding & Sponsors
Funding source category [1] 290920 0
Hospital
Name [1] 290920 0
Hospital Universitario Virgen Macarena
Address [1] 290920 0
Avd. Dr Fedriani, 3, 41071 Seville
Country [1] 290920 0
Spain
Primary sponsor type
Individual
Name
Guillermo Izquierdo Ayuso
Address
Hospital Universitario Virgen Macarena, Unidad de Esclerosis Multiple. Edificio Policlinico, Planta 1ª puerta 106.
Avd. Dr Fedriani, 3, 41071 Seville
Country
Spain
Secondary sponsor category [1] 289606 0
None
Name [1] 289606 0
Address [1] 289606 0
Country [1] 289606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292524 0
COMITE DE ETICA DE LA INVESTIGACION DE CENTRO HOSPITAL UNIVERSITARIO VIRGEN MACARENA
Ethics committee address [1] 292524 0
Hospital Virgen Macarena
Avda. Dr. Fedriani, 3 - Unidad de Investigación 2ª planta Sevilla 41071 Sevilla

Ethics committee country [1] 292524 0
Spain
Date submitted for ethics approval [1] 292524 0
Approval date [1] 292524 0
10/10/2012
Ethics approval number [1] 292524 0
1896

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55606 0
Ms Anja Hochsprung
Address 55606 0
Neurological Physiotherapy Departament, Hospital Universitario Virgen Macarena, Avd. Dr Fedriani, 3, 41071 Seville (Spain)
Country 55606 0
Spain
Phone 55606 0
+34 671562074
Fax 55606 0
Email 55606 0
ahalcala@hotmail.com
Contact person for public queries
Name 55607 0
Ms Anja Hochsprung
Address 55607 0
Neurological Physiotherapy Departament, Hospital Universitario Virgen Macarena, Avd. Dr Fedriani, 3, 41071 Seville (Spain)
Country 55607 0
Spain
Phone 55607 0
+34 671562074
Fax 55607 0
Email 55607 0
ahalcala@hotmail.com
Contact person for scientific queries
Name 55608 0
Ms Anja Hochsprung
Address 55608 0
Neurological Physiotherapy Departament, Hospital Universitario Virgen Macarena, Avd. Dr Fedriani, 3, 41071 Seville (Spain)
Country 55608 0
Spain
Phone 55608 0
+34 671562074
Fax 55608 0
Email 55608 0
ahalcala@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary