Clinical trial NCT05185986: Investigating the Home-based RCTs of Pilates Exercises and Cognitive Rehabilitation Exercises for Executive Functions and Anxiety in MS.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Executive Functions
Anxiety
Pilates
Cognitive Rehabilitation
Lead sponsor: Arak University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Pardis Specialized Wellness Institute
First posted: 2022-01-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: OTHER

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.

Detailed description: Since the onset of pandemic conditions in 2020 and the increase of lockdowns, almost all rehabilitation programs for MS patients in Iran were suspended, it is necessary to study the effects of home-based cognitive and physical interventions to improve executive functions and anxiety in MS patients. The present study will be conducted to investigate the effects of home-based Pilates exercises and the combination of home-based Pilates exercises with home-based cognitive rehabilitation as well as to compare the effects of these two interventions on executive functions and anxiety in MS patients. In this study, participants will be divided into two experimental groups and a control group. The research process and the reason for conducting the research will be explained to the candidates by lead researcher and the final participants will sign the research participation form. All 51 final participants will be identified by a code and their identity information will not be disclosed, and in order to avoid any bias, each code will be randomly divided into three groups randomly. Pre-test will be taken from all three groups before the intervention. Experiment group 1 will perform a home-based Pilates video training program for 8 weeks, two sessions a week at home, and will also pay attention to exercise-related tips for MS patients determined by specialists. At the same time, Experiment group 2 will be asked to perform home-based cognitive rehabilitation program for 8 weeks, 3 seasons a week at home, in addition to home-based Pilates exercises same as experimental group 1. Group 3 will also be on the waiting list as a control group and will not receive any interventions for 8 weeks. At the end of 8 week intervention, Pilates training packages and cognitive exercises will be provided to the control group for their own use. During the 8 weeks of the intervention, the Pilates instructor and the cognitive rehabilitation specialist will contact the subjects on a weekly basis and monitor their performance. Subjects will also be able to contact the researchers and express their questions and problems. Also, they will be able to hold online meetings with research facilitators for solving the problems and educating the exercises. During the 8 weeks of the intervention, if subjects have problems such as COVID-19 affection, coronary heart disease, muscle problems, relapse, and failure to perform more than 4 sessions of exercise, they will be excluded from the study by the lead researcher. In order to fully perform the exercises for people who do not perform up to 4 sessions of exercises, 2 weeks can be added to the intervention period, which will be applied by the lead researcher. After complete implementation of the intervention, post-test will be taken from all 3 groups and the results will be compared to the baseline and relative to each other.

Eligibility criteria: Inclusion Criteria:

* physician-diagnosed Multiple Sclerosis
* EDSS score \< 5
* Free from any other significant physical or psychiatric condition
* Have no previous Pilates experience

Exclusion Criteria:

* having cognitive or physical exercises at least from 3 months before intervention.
* Using psychiatric drugs or being under psychotherapy.

Primary outcomes:
measure: change from baseline total number of cWMI
timeFrame: Baseline, week 8
measure: change from baseline total time of cTOL
timeFrame: Baseline, week 8
measure: change from baseline score of BAI
timeFrame: Baseline, week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: MS society of Isfahan
Study officials:
affiliation: University of Arak
name: Tooraj Sepahvand, Phd.
role: STUDY_DIRECTOR
affiliation: Islamic Azad University of Khorasgan
name: Mohammad Ali Tabibi, Phd.
role: STUDY_CHAIR
affiliation: Isfahan University of Medical Sciences
name: Masoud Etemadifar, Phd.
role: STUDY_CHAIR
affiliation: University of Arak
name: Amir Hossein Kazemi, MS.
role: PRINCIPAL_INVESTIGATOR
References: