Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis

NCT05993819 | Completed

• 1 other identifier: p.t.REC/012/004535
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis

Conditions

Multiple Sclerosis

Keywords

cognitive behaviour therapy; Pilates exercise; palance; walking

Outcome Measures

Primary Outcomes (2)

• walking assessment

  walking will be assessed by walkway device

  up to eight weeks

• balance

  balance will be assessed by biodex balance device

  up to eight weeks

Secondary Outcomes (2)

• fatigue

  up to eight weeks

• life disability

  up to eight weeks

Study Arms (2)

pilates based core stability training and congnitive therapy

EXPERIMENTAL

the patients will receive pilates and cognitive therapy three times a week for eight weeks

Other: pilates based core stability training and congnitive therapy

Pilates based core stability training

ACTIVE COMPARATOR

the patients will receive pilates three times a week for eight weeks

Other: Pilates based core stability training

Interventions

pilates based core stability training and congnitive therapy OTHER

Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all.the patients also will receive cognitive behavioural therapy.The CBT manual was written specifically for this trial. The sessions were collaborative in style, and the therapist used Socratic questioning wherever possible. The main aim was to challenge any behavioral, cognitive, emotional and external factors that may be contributing to MS fatigue.

pilates based core stability training and congnitive therapy

Pilates based core stability training OTHER

Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all. The exercises were gradually made more difficult to increase the stabilization of the trunk by gradually reducing the support surface, increasing the extremity loading, and adding various materials.Exercises were progressed every 2 weeks in both groups and were performed with 10 repetitions for the first 4 weeks and 15 repetitions for the next 4 weeks.

Pilates based core stability training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent.
• Age over 18 years
• All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017
• Both males and females were included

You may not qualify if:

• Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS that might affect the treatment results-
• serious cognitive problems; performed regular exercise; were involved in another physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)
• Pregnant were not included.
• Individuals who had an exacerbation during the treatment period

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Alshaymaa Shaaban Abdelazeim

Giza, Dokki, 11351, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator. alshaymaa shaaban abd el-azeim

Model Details: pilates and cognitive behavioral therapy

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: August 15, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

EG (1)