Investigating the Home-based RCTs of Pilates Exercises and Cognitive Rehabilitation Exercises for Executive Functions and Anxiety in MS.
Comparison the Home-based Pilates Exercises and the Combination of Home-based Pilates Exercises With Home-based Cognitive Rehabilitation Exercises on Executive Functions and Anxiety in Multiple Sclerosis Patients.
1 other identifier
interventional
51
1 country
1
Brief Summary
The main purpose of this study is to evaluate the effectiveness of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation exercises, also to compare the effects of these two home-based interventions on executive functions and anxiety in MS patients. 51 MS patients of Isfahan MS society will be considered as sample and will be divided randomly into three groups of 17 participants. The first group is home-based Pilates exercises group, the second group is a combination of home-based Pilates exercises and home-based cognitive rehabilitation exercises and the third group is the waiting list group that is considered as the control group. Patients' scores on executive functions and anxiety will be assessed before and after 8 weeks of intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Dec 2021
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2021
CompletedFirst Submitted
Initial submission to the registry
December 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2022
CompletedMarch 15, 2022
March 1, 2022
2 months
December 23, 2021
March 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
change from baseline total number of cWMI
Computerized Working Memory Index (cWMI) The computerized figures width subscale of the Wechsler IQ scale, is used to measure working memory. Figures Width is the working memory subscale of the fourth edition of the Wechsler Intelligence Scale, which consists of two parts: Forward Figures Width and Inverted Figures Width and The sum of a person's scores in these two parts constitutes the total score of the person in this subscale.
Baseline, week 8
change from baseline total time of cTOL
Computerized Tower Of London Task (cTOL) a computerized program in which patients are shown two pictures simultaneously of a goal board and a test board and are instructed to use the fewest possible moves to match the two boards. Each baseline and 8 week set of 12 problems consists of the same number of 2, 3, 4 or 5 move problems and has the same average difficulty level. Every problem could be repeated 3 times to be solved by participants. The dependent variables are the total number of task and the total time spent solving the problem (less time is better) and the delayed time or time to first move (less time is better).
Baseline, week 8
change from baseline score of BAI
Beck Anxiety Inventory (BAI) Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and 26 - 63 as "Severe".
Baseline, week 8
Study Arms (3)
Home based Pilates exercises
EXPERIMENTALThis group will perform two weekly sessions of Pilates for eight weeks, completed with at least 48-hours between sessions, in their own home, supported by a DVD developed and previously implemented and evaluated by the lead researcher in a feasibility trial among people with Multiple Sclerosis. Each Pilates session will last approximately one hour and is comprised of seven Pilates warm-up exercises and fourteen mat-based beginner's level exercise. Four repetitions of each Pilates movement will be performed during sessions in the first two weeks, with intensity being self-regulated by the participant based on level of physical condition. Repetitions will gradually progress at biweekly intervals, resulting in ten repetitions being performed for the final two weeks of the trial (Weeks 7 and 8). Six post-training stretches will be maintained for a minimum of thirty seconds.
Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises
EXPERIMENTALIn addition to performing home-based Pilates exercises described in arm 1, this group will also perform home-based cognitive rehabilitation exercises for 8 weeks and 3 sessions per week. The interval between each session is at least 48 hours and each session will take between 30 to 45 minutes. Cognitive rehabilitation exercises are in pen and paper and each session includes two exercises in the areas of planning, cognitive organization, cognitive flexibility and working memory. All exercises will be explained to the subjects by a cognitive rehabilitation specialist, and in addition, explanations of all the exercises in each session will be available for participants in the separate voices. During the intervention period, in addition to the Pilates specialist, the cognitive rehabilitation specialist contacts the group 2 participants on a weekly basis and monitors their rehabilitation exercises.
Waiting list group
OTHERThis group is the waiting list group and acts as a control group and will be instructed to maintain their preintervention physical and cognitive activity levels during the intervention. After 8 weeks of intervention, Pilates exercises and cognitive rehabilitation exercises will be provided to the participants of this group for their own use.
Interventions
The Home-based Pilates is the two Pilates classes at home, twice weekly, for a period of eight weeks.
Home-based Cognitive Rehabilitation is the 3 sessions per week and 8 weeks of cognitive rehabilitation exercises at home. Each session consists of two Pen and paper exercises. Exercises are active in the areas of planning, cognitive organization, cognitive flexibility and working memory. Each session will take 30 to 45 minutes.
This group act as the control group and will maintain their physical and cognitive activities as the preintervention. Following the 8 weeks of intervention the home-based pilates and cognitive rehabilitation exercises will be provided to them for their own use.
Eligibility Criteria
You may qualify if:
- physician-diagnosed Multiple Sclerosis
- EDSS score \< 5
- Free from any other significant physical or psychiatric condition
- Have no previous Pilates experience
You may not qualify if:
- having cognitive or physical exercises at least from 3 months before intervention.
- Using psychiatric drugs or being under psychotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MS society of Isfahan
Isfahan, 83, Iran
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tooraj Sepahvand, Phd.
University of Arak
- STUDY CHAIR
Mohammad Ali Tabibi, Phd.
Islamic Azad University of Khorasgan
- STUDY CHAIR
Masoud Etemadifar, Phd.
Isfahan University of Medical Sciences
- PRINCIPAL INVESTIGATOR
Amir Hossein Kazemi, MS.
University of Arak
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The principal investigator was blinded to participant allocation, and the analyses were performed blinded to the group. Participants' individual identification numbers assigned at baseline were used during the course of the trial. Identifying information were removed, such that no participant could be identified in the working dataset through one, or a combination of different variables.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc. University of Arak
Study Record Dates
First Submitted
December 23, 2021
First Posted
January 11, 2022
Study Start
December 20, 2021
Primary Completion
February 28, 2022
Study Completion
March 7, 2022
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- starting march 2024
- Access Criteria
- Only for researchers who are studying on the related subjects. IPD sharing via principal investigator's email address will be available.
Participants' identities will not be shared. Each participant is identified by a code and the data obtained from the assessment of the participants by the research tools and the demographic data of the participants including age, education, marital status and EDSS score will be available via the email of the principal researcher.