NCT04546880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

August 29, 2020

Last Update Submit

September 4, 2020

Conditions

Keywords

Chronic Low back painBreathing exercisesCore StabilizationAnxietySleep

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group 1:Breathing and Stabilization Exercise Group

EXPERIMENTAL

Breathing exercises combined with stabilization exercises

Other: Breathing exercisesOther: Stabilization exercises

Group 2: Stabilization Exercise Group

ACTIVE COMPARATOR

Only Stabilization exercises therapy

Other: Stabilization exercises

Interventions

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.

Group 1:Breathing and Stabilization Exercise Group

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.

Group 1:Breathing and Stabilization Exercise GroupGroup 2: Stabilization Exercise Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2020

First Posted

September 14, 2020

Study Start

June 15, 2018

Primary Completion

December 31, 2018

Study Completion

February 20, 2019

Last Updated

September 14, 2020

Record last verified: 2020-09

Locations