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

September 4, 2020 updated by: Aysenur Tuncer, Hasan Kalyoncu University
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey, 27410
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1:Breathing and Stabilization Exercise Group
Breathing exercises combined with stabilization exercises

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.

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.

Active Comparator: Group 2: Stabilization Exercise Group
Only Stabilization exercises therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Low Back Pain at 8 weeks
Time Frame: Baseline, 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.
Baseline, 8 weeks
Change from Baseline in Fatigue at 8 weeks
Time Frame: Baseline, 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.
Baseline, 8 weeks
Change from Baseline in Anxiety at 8 weeks
Time Frame: Baseline, 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.
Baseline, 8 weeks
Change from Baseline in Sleep quality at 8 weeks
Time Frame: Baseline, 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.
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

August 29, 2020

First Submitted That Met QC Criteria

September 4, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low-back Pain

Clinical Trials on Breathing exercises

3
Subscribe