Chronic Low-back PainNCT04546880
Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs
A study testing Breathing exercises and Stabilization exercises in people with Chronic Low-back Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Breathing exercises and Stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Breathing exercises, Stabilization exercises
- Keywords
- Chronic Low back pain, Breathing exercises, Core Stabilization, Anxiety, Sleep
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Breathing and Stabilization Exercise Group | Experimental | Breathing exercises combined with stabilization exercises Receives: Other: Breathing exercises; Other: Stabilization exercises |
| Group 2: Stabilization Exercise Group | Active comparator | Only Stabilization exercises therapy Receives: Other: Stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start15 Jun 2018
- Primary completion31 Dec 2018
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Tuncer, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546880
- Sponsor's protocol ID
- HKUatuncer
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises in the Mothers of Children With Special Health Care Needs
- ClinicalTrials.gov ID
- NCT04546880
- Acronym / sponsor ID
- HKUatuncer
- Conditions
- Chronic Low-back Pain
- Keywords
- Chronic Low back pain, Breathing exercises, Core Stabilization, Anxiety, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Breathing and Stabilization Exercise Group | Experimental | Other: Breathing exercises, Other: Stabilization exercisesBreathing exercises combined with stabilization exercises |
| Group 2: Stabilization Exercise Group | Active comparator | Other: Stabilization exercisesOnly Stabilization exercises therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exercisesBreathing 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. | Other | Group 1:Breathing and Stabilization Exercise Group |
| Stabilization exercisesTraining 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. | Other | Group 1:Breathing and Stabilization Exercise Group, Group 2: Stabilization Exercise Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises and Stabilization exercises in people with Chronic Low-back Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Low Back Pain at 8 weeks (time frame: Baseline, 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.