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Completed

NCT Number: NCT04546880

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, 27410, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breathing exercises

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 14, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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