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Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breathing exercises
Stabilization exercises
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic Low back pain, Breathing exercises, Core Stabilization, Anxiety, Sleep

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary caregiver of the child
  • Suffering from LBP for at least three months
  • Lumbar instability
  • Absence of radiculopathy or other damages to the spine
  • Not receiving any types of physical therapy during the trial or at least six months prior to the study
  • Enough physical autonomy to participate in the physical activities
  • Be volunteer
  • Be compliant for the study

Exclusion Criteria:

  • Taking any anti-depressant medications and/or having psychotherapy
  • Any surgery within the last 3 months
  • Be pregnant
  • Presence of dysfunction of the musculoskeletal system during the study
  • Participation rate lower than 80% of the program schedule

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1:Breathing and Stabilization Exercise Group

Group 2: Stabilization Exercise Group

Arm Description

Breathing exercises combined with stabilization exercises

Only Stabilization exercises therapy

Outcomes

Primary Outcome Measures

Change from Baseline in Low Back Pain at 8 weeks
Visual Analog Scale were used where patients were asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain at the baseline and the end of 8 weeks intervention.
Change from Baseline in Fatigue at 8 weeks
Fatigue Severity Scale was used where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Change from Baseline in Anxiety at 8 weeks
Spielberger's State-Trait Anxiety Inventory was used to measure state and trait anxiety with 20 item self-report rating scale. The range of total scores was 20-80, and higher scores indicated higher levels of anxiety.
Change from Baseline in Sleep quality at 8 weeks
Pittsburg Sleep Quality Index was used to assess sleep quality consisting of a total of 24 questions, 19 of which were self-rated by the patient, and 5 of which were answered by the partner of the patient. The total scores ranged between 0 and 21 points with higher values representing worse sleep quality.

Secondary Outcome Measures

Full Information

First Posted
August 29, 2020
Last Updated
September 4, 2020
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT04546880
Brief Title
Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs
Official Title
Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

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

5. Study Description

Brief Summary
The aim of the study is to determine the effectiveness of breathing exercises combined with core stabilization exercises in mothers with chronic non-specific low back pain of children with special health care needs.
Detailed Description
A total of 46 mothers having children with special health care needs participate in the study. Twenty-three mothers in the experimental group receive stabilization exercises with breathing exercises 3 times a week for 8 weeks while 23 mothers in the control group receive only stabilization exercises during the same period of time. Each exercise session lasts about 60 minutes and was performed 3 days per week, for 8 weeks. All mothers in both groups perform 15 minutes warm-up stretching exercises prior to the core exercises and 10 minutes cool-down exercises at the end of each session. Breathing with the stabilization exercise group receives breathing exercises before the stabilization exercise program. A one-hour theoretical training is given to the mothers about the techniques of diaphragmatic and pursed-lip breathing at the beginning of the study. The pursed-lip breathing is one step further to the diaphragmatic breathing. Patients are instructed to do breathing exercises during the stabilization exercises, in which patients focus on their breathing circle, time, and movement while doing the stabilization exercises. All 46 mothers in both groups are given a one-hour training about the stabilization exercises before starting the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. Closed-chain segmental control exercises, a series of weight-bearing exercises, and open kinetic chain exercises to promote distal stability are performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic Low back pain, Breathing exercises, Core Stabilization, Anxiety, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1:Breathing and Stabilization Exercise Group
Arm Type
Experimental
Arm Description
Breathing exercises combined with stabilization exercises
Arm Title
Group 2: Stabilization Exercise Group
Arm Type
Active Comparator
Arm Description
Only Stabilization exercises therapy
Intervention Type
Other
Intervention Name(s)
Breathing exercises
Intervention Description
Breathing exercises consist of the techniques of diaphragmatic and pursed-lip breathing. During the diaphragmatic breathing, attention is focused on the correct abdominal breathing. The pursed-lip breathing is one step further to the diaphragmatic breathing and a technique designed to have control time and volume over breathing.
Intervention Type
Other
Intervention Name(s)
Stabilization exercises
Intervention Description
Training about the concepts of stabilization and abdominal bracing is given before starting to the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface. The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability.
Primary Outcome Measure Information:
Title
Change from Baseline in Low Back Pain at 8 weeks
Description
Visual Analog Scale were used where patients were asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain at the baseline and the end of 8 weeks intervention.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Fatigue at 8 weeks
Description
Fatigue Severity Scale was used where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Anxiety at 8 weeks
Description
Spielberger's State-Trait Anxiety Inventory was used to measure state and trait anxiety with 20 item self-report rating scale. The range of total scores was 20-80, and higher scores indicated higher levels of anxiety.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Sleep quality at 8 weeks
Description
Pittsburg Sleep Quality Index was used to assess sleep quality consisting of a total of 24 questions, 19 of which were self-rated by the patient, and 5 of which were answered by the partner of the patient. The total scores ranged between 0 and 21 points with higher values representing worse sleep quality.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary caregiver of the child Suffering from LBP for at least three months Lumbar instability Absence of radiculopathy or other damages to the spine Not receiving any types of physical therapy during the trial or at least six months prior to the study Enough physical autonomy to participate in the physical activities Be volunteer Be compliant for the study Exclusion Criteria: Taking any anti-depressant medications and/or having psychotherapy Any surgery within the last 3 months Be pregnant Presence of dysfunction of the musculoskeletal system during the study Participation rate lower than 80% of the program schedule
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27410
Country
Turkey

12. IPD Sharing Statement

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Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs

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