Investigating the Home-based RCTs of Pilates Exercises and Cognitive Rehabilitation Exercises for Executive Functions and Anxiety in MS.

Arak University of Medical Sciences

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: waiting list group; Behavioral: Home-Based Pilates exercise; Other: Home-based Cognitive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05185986

6436

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

Home based Pilates exercises

Experimental group

Description:

This 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.

Treatment:

Behavioral: Home-Based Pilates exercise

Combination of Home-based Pilates exercises and Home-based Cognitive Rehabilitation exercises

Experimental group

Description:

In 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.

Treatment:

Behavioral: Home-Based Pilates exercise

Other: Home-based Cognitive Rehabilitation

Waiting list group

Other group

Description:

This 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.

Treatment:

Other: waiting list group