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Comparison of Pilates &Home Exercise Programs on Muscle Strength in Paraplegic Patients

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reformer Pilates
Home Exercise
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries focused on measuring spinal cord injuries, reformer pilates, home exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Volunteering for study
  • Lesion level: T2 and below diagnosed with SCI
  • Lesion duration over 2 years
  • Ambulation in wheelchair
  • To ensure randomization, SCI patients must be a member of Turkish Spinal Cord Injury Association and which should not be included in any study group.

Exclusion Criteria:

  • Severe psychiatric disorder
  • General condition disorder (heart failure, lung failure)
  • Intolerably shoulder pain during exercise

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reformer pilates group

Home exercise group

Arm Description

Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.

A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.

Outcomes

Primary Outcome Measures

the upper extremity muscle strength
measure the upper extremity muscle strength with a hand dynamometer

Secondary Outcome Measures

the Short Form(36) Health Survey (SF-36)
The SF-36 is a measure of health status.It consists of eight scaled scores, which are the weighted sums of the questions in their section. The lower the score the more disability.
Spinal Cord Independence Measure version III (SCIM-III)
SCIM-III is a measurement tool for determining the level of function in spinal cord injury

Full Information

First Posted
April 22, 2020
Last Updated
April 22, 2020
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04360447
Brief Title
Comparison of Pilates &Home Exercise Programs on Muscle Strength in Paraplegic Patients
Official Title
Comparison of the Effects of Reformer Pilates and Home Exercise Programs on Upper Extremity Muscle Strength in Paraplegic Patients: Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Paraplegic patients to be included in the study were divided into 2 groups by randomization and it was planned to apply reformer pilates or home exercise programs for 8 weeks. It was aimed to compare upper extremity muscle strengths, Spinal Cord Independence Measure version III (SCIM-III) and the Short Form(36) Health Survey (SF-36) data before and after treatment.
Detailed Description
Spinal cord injuries (SCI) are injuries that occur as a result of compression, incision or contusion of the spinal cord, which extends from foramen magnum to cauda equina.These patients experience various complications and organ system damage in the chronic period.Their self-dependence is affected by the level of injury. One of the most important factors affecting the self-dependence of people with SCI is the strength of the upper extremity.Strong upper extremities are needed for independent transfer from bed. SCI patients member of Turkish Spinal Cord Injury Association, according to the criteria for inclusion in the study patient list was created. In accordance with the sample size with the random numbers prepared with a computer program from this list, 18 people were planned to be included in the study. The patients were planned to be randomly divided into the study and control groups.Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks; A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.It was planned to record the demographic data of the patients (age, gender, occupation, additional disease).It was planned to fill the SF-36 form to measure the quality of life of the patients, SCIM-III forms to evaluate functionally and measure the upper extremity muscle strength with a hand dynamometer. At the end of 8 weeks, the patients were called for an examination, and SF-36, SCIM-III forms were filled and muscle strength was measured, and the comparison was aimed within the group and between the groups.In our study, our aim is to demonstrate the applicability of the reformer pilates program in SCI patients. In addition, to show the effects of home exercise program and reformer pilates programs on upper extremity muscle strength in SCI patients with multiple comparison tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injuries, reformer pilates, home exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reformer pilates group
Arm Type
Experimental
Arm Description
Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.
Arm Title
Home exercise group
Arm Type
Active Comparator
Arm Description
A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Reformer Pilates
Intervention Description
Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Home Exercise
Intervention Description
A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.
Primary Outcome Measure Information:
Title
the upper extremity muscle strength
Description
measure the upper extremity muscle strength with a hand dynamometer
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the Short Form(36) Health Survey (SF-36)
Description
The SF-36 is a measure of health status.It consists of eight scaled scores, which are the weighted sums of the questions in their section. The lower the score the more disability.
Time Frame
8 weeks
Title
Spinal Cord Independence Measure version III (SCIM-III)
Description
SCIM-III is a measurement tool for determining the level of function in spinal cord injury
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volunteering for study Lesion level: T2 and below diagnosed with SCI Lesion duration over 2 years Ambulation in wheelchair To ensure randomization, SCI patients must be a member of Turkish Spinal Cord Injury Association and which should not be included in any study group. Exclusion Criteria: Severe psychiatric disorder General condition disorder (heart failure, lung failure) Intolerably shoulder pain during exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma N Kesiktaş, Assoc. Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24614829
Citation
Dost G, Dulgeroglu D, Yildirim A, Ozgirgin N. The effects of upper extremity progressive resistance and endurance exercises in patients with spinal cord injury. J Back Musculoskelet Rehabil. 2014;27(4):419-26. doi: 10.3233/BMR-140462.
Results Reference
background
PubMed Identifier
27002667
Citation
Yildirim A, Surucu GD, Karamercan A, Gedik DE, Atci N, Dulgeroglu D, Ozgirgin N. Short-term effects of upper extremity circuit resistance training on muscle strength and functional independence in patients with paraplegia. J Back Musculoskelet Rehabil. 2016 Nov 21;29(4):817-823. doi: 10.3233/BMR-160694.
Results Reference
background
PubMed Identifier
16554684
Citation
Sipski ML, Richards JS. Spinal cord injury rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):310-42. doi: 10.1097/01.phm.0000202105.87011.bf. No abstract available.
Results Reference
background
PubMed Identifier
22330108
Citation
Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.
Results Reference
background
PubMed Identifier
12851498
Citation
Gibson KL. Caring for a patient who lives with a spinal cord injury. Nursing. 2003 Jul;33(7):36-41; quiz 42. doi: 10.1097/00152193-200307000-00031. No abstract available.
Results Reference
background
PubMed Identifier
15456347
Citation
Jacobs PL, Nash MS. Exercise recommendations for individuals with spinal cord injury. Sports Med. 2004;34(11):727-51. doi: 10.2165/00007256-200434110-00003.
Results Reference
background

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Comparison of Pilates &Home Exercise Programs on Muscle Strength in Paraplegic Patients

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