Investigation of the Effects of Pilates Training Combined with Whole Body Vibration on Balance and Mobility in Individuals with Multiple Sclerosis

NCT ID: NCT06829680

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-28
• Study Completion Date: 2024-09-21

Brief Summary

The aim of this study is to investigate the effects of Pilates training combined with whole-body vibration (WBV) on balance and mobility in individuals with Multiple Sclerosis (MS). The main questions it aims to answer are:

• Are the improvements in core stability, lower limb functional muscle strength, balance and mobility obtained with Pilates training combined with WBV (Pilates-WBV) in individuals with MS greater than with Pilates training alone?
• Are the improvements in upper extremity performance and fatigue obtained with Pilates-WBV training in individuals with MS greater than with Pilates training alone?

Researchers will compare Pilates-WBV training with a group that received Pilates training alone to see if there is any additional benefit.

Participants will:

• Take Pilates-WBV or Pilates training twice a week for 6 weeks
• Be evaluated with pre- and post-training

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Pilates-WBV

17 participants received Pilates and WBV training twice a week for 6 weeks. In each training session, the participants rested for 10 minutes between Pilates and WBV training.

Group Type: EXPERIMENTAL

Pilates

Intervention Type: OTHER

The participants were given a total of 12 sessions of Pilates training, applied twice a week for 6 weeks, and each session lasted approximately 60 minutes. The 60-min session consisted of warm up and cool down (5 min each) and the main active phase (50 min).

In the main active phase; "One leg stretch", "Double leg stretch", "One leg circle", "Heels together toes apart", "Shoulder bridge", "The hundreds", "Chest lift", "Criss cross", "Clam", "Side bend", "Arm opening", "Cobra", "Breast stroke", "Swimming", "Modified push-up", "Plank", "Leg pull prone" and "Squat" exercises were performed. The exercises were applied with 10 repetitions in the first 3 weeks and with 20 repetitions in the last 3 weeks.

Whole Body Vibration

Intervention Type: OTHER

The participants were given a total of 12 sessions of WBV training, applied twice a week for 6 weeks.

The vibration parameters were set as frequency: 20 Hz, amplitude: 2-3 mm, duration: 30-60 s and rest period: 60 s. The application time of the WBV training was 30 s for the first two weeks, 45 s for the next two weeks and 60 s for the last two weeks.

The individuals were asked to maintain squat, shoulder bridge and quadruped positions statically for the first two weeks. Starting from the third week, they were asked to perform reciprocal upper extremity flexion and extension movements during the positions. The application was repeated 3 times in each position.

Pilates

17 participants received Pilates training twice a week for 6 weeks

Group Type: ACTIVE_COMPARATOR

Pilates

Intervention Type: OTHER

The participants were given a total of 12 sessions of Pilates training, applied twice a week for 6 weeks, and each session lasted approximately 60 minutes. The 60-min session consisted of warm up and cool down (5 min each) and the main active phase (50 min).

In the main active phase; "One leg stretch", "Double leg stretch", "One leg circle", "Heels together toes apart", "Shoulder bridge", "The hundreds", "Chest lift", "Criss cross", "Clam", "Side bend", "Arm opening", "Cobra", "Breast stroke", "Swimming", "Modified push-up", "Plank", "Leg pull prone" and "Squat" exercises were performed. The exercises were applied with 10 repetitions in the first 3 weeks and with 20 repetitions in the last 3 weeks.

Interventions

Pilates

The participants were given a total of 12 sessions of Pilates training, applied twice a week for 6 weeks, and each session lasted approximately 60 minutes. The 60-min session consisted of warm up and cool down (5 min each) and the main active phase (50 min).

In the main active phase; "One leg stretch", "Double leg stretch", "One leg circle", "Heels together toes apart", "Shoulder bridge", "The hundreds", "Chest lift", "Criss cross", "Clam", "Side bend", "Arm opening", "Cobra", "Breast stroke", "Swimming", "Modified push-up", "Plank", "Leg pull prone" and "Squat" exercises were performed. The exercises were applied with 10 repetitions in the first 3 weeks and with 20 repetitions in the last 3 weeks.

Intervention Type: OTHER

Whole Body Vibration

The participants were given a total of 12 sessions of WBV training, applied twice a week for 6 weeks.

The vibration parameters were set as frequency: 20 Hz, amplitude: 2-3 mm, duration: 30-60 s and rest period: 60 s. The application time of the WBV training was 30 s for the first two weeks, 45 s for the next two weeks and 60 s for the last two weeks.

The individuals were asked to maintain squat, shoulder bridge and quadruped positions statically for the first two weeks. Starting from the third week, they were asked to perform reciprocal upper extremity flexion and extension movements during the positions. The application was repeated 3 times in each position.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Definitive Multiple Sclerosis diagnosed by a specialist
• Expanded Disability Status Scale (EDSS) score between 0-5
• Accepting participation in the study voluntarily

Exclusion Criteria

• An MS attack within the last three months
• Pregnancy
• Endoprosthesis or electronic implant
• A cardiovascular, pulmonary or orthopedic disease
• A disease that can affect the immune system, such as infection or cancer
• Additional neurological disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Güçlü Gündüz

Profesor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu GUCLU GUNDUZ, Professor Doctor

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Abbasi M, Kordi Yoosefinejad A, Poursadeghfard M, Parsaei Jahromi F, Motealleh A, Sobhani S. Whole body vibration improves core muscle strength and endurance in ambulant individuals with multiple sclerosis: A randomized clinical trial. Mult Scler Relat Disord. 2019 Jul;32:88-93. doi: 10.1016/j.msard.2019.04.028. Epub 2019 Apr 30.

Reference Type: BACKGROUND

PMID: 31071658 (View on PubMed)

Other Identifiers

2023-1602

Identifier Type: -

Identifier Source: org_study_id