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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546880
• Other study ID #: HKUatuncer
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: February 20, 2019

Study information

• Verified date: September 2020
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 20, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain
• Respiratory Aspiration

Intervention

Other:
• Breathing 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.
• Stabilization exercises
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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8 weeks
Primary	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.	Baseline, 8 weeks
Primary	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.	Baseline, 8 weeks
Primary	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.	Baseline, 8 weeks