Lower Cross SyndromeNCT06172192
EFFECTS OF CORE STRENGTHENING WITH RESISTIVE VERSUS NON-RESISTIVE DIAPHRAGMATIC TRAINING ON CORE ENDURANCE IN LOWER CROSS SYNDROME
A study testing Core Strengthening, Self-Diaphragm breathing exercises and Resistive-Diaphragm breathing exercises in people with Lower Cross Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomised control trial and the purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome. Read more about this study
- Who is it for?
- Ages 19 to 30 years
- Conditions the study is for
- Lower Cross Syndrome
- What is being tested?
- Core Strengthening, Self-Diaphragm breathing exercises and Resistive-Diaphragm breathing exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2023to 20 Jan 2024
- 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 19 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 19-30 years
- Both genders
- Positive modified Thomas test
- Positive prone hip extension strength test
- Positive trunk flexion strength test
- Tight erector spinae
Show all 11Show fewer
- Asia pacific BMI normal and overweight (18.5-24.9 Kg/m2)
- Local intermittent lumbar pain
- Mild to moderate pain (NPRS 1-6)
- Painless movement and activity
- Pain only produced by sustained loading in relevant position, which is then relieved on moving from that posture
Who cannot join
- Shoulder pain
- Acute flare LBP
- Centralization and peripheralization of pain (21)
- Intermittent pain at limited end range (21)
- Leg symptoms when walking, eased in flexion (Signs of stenosis) (21)
- Pain due to repetitive movement (21)
Show all 12Show fewer
- Paresthesia/numbness (21)
- Structural deformity (Kyphosis, lordosis, scoliosis, spondylosis, spondylolysis, spondylolisthesis)
- Curve reversal (21)
- Pregnancy
- Post surgery
- Degenerative and inflammatory spinal diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Qurat ul Ain Saeed, MS-OMPT, 03315562889, quratulain.saeed@fui.edu.pk
About this study
This study is a randomised control trial and the purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.
Read the detailed description
The purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.
Core stability of young adults (age: 19-30 years) will be determined using McGill's muscular endurance test battery:
- Flexor endurance test
- Extensor endurance test
- Right lateral endurance test
- Left lateral endurance test Scores will be taken three times for each test; the average of each text will be noted for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. McGill's Torso Muscular Endurance Test Battery will be used and baseline and post-intervention scores will be recorded.
- Conditions
- Lower Cross Syndrome
- Being tested
- Core Strengthening, Self-Diaphragm breathing exercises, Resistive-Diaphragm breathing exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core StrengtheningProcedure or surgery
- Warm up phase Following exercise would be performed in warm up. Jump rope, Cross jacks, Standing side crunch, Mountain climbers, Scissor skier, Criss cross crunches, Reverse lunge high kick, Inchworm, Hip circles, Bent over.
- Core Strengthening: Abdominal bracing, Bracing with heel slides, Bracing with leg lifts, Bracing with bridging, Bracing in standing, Bracing with standing row exercise, Quadruped arm lifts with bracing, Quadruped leg lifts with bracing, Quadruped alternate arm and leg lifts with bracing , Oblique abdominals
- Cool down phase: Following exercise would be performed for cood down: child pose, Ab stretch, cat cow stretch, hip stretch, oblique stretch, standing forward bend.
After performance of core strengthening protocol, group A will perform self-diaphragmatic breathing exercises while group B will perform resistive diaphragmatic breathing exercise.
Self-Diaphragm breathing exercisesProcedure or surgery
Participants will place one hand on the chest and other on the abdomen, feeling the swelling of the stomach and the movement of the chest. It will be performed in supine position.
Supervised breathing exercises in two sets for 15 minutes with 5 minutes break between sets and 10 minutes rest after it will be performed
Resistive-Diaphragm breathing exercisesProcedure or surgery
Participants will place one hand on the chest and another on the sand bag placed over abdomen. This sand bag weighing 3-5 Kgs will provide resistance to breathing. These exercises will be performed in supine position. We will adjust the weight of the sandbag as per individual's level of 11-13 of 'Rating of Perceived Exercise (RPE)'.
Supervised breathing exercises in two sets for 15 minutes with 5 minutes break between sets and 10 minutes rest after it will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will perform Core Strengthening exercises. In addition to core strengthening protocol, non-resistive Diaphragmatic training group will perform self-diaphragm breathing exercises
Core strengthening protocol will comprise of following three phases:
1. Warm up phase:
2. Core strengthening phase:
3. Cool down phase:
After performance of Core Strengthening protocol, Group A will perform Self-Diaphragmatic breathing exercises. Receives: Procedure: Core Strengthening; Procedure: Self-Diaphragm breathing exercises |
| Group B | Experimental | Group B will perform Core Strengthening exercises. In addition to core strengthening protocol, resistive Diaphragmatic training group will perform resisted-diaphragm breathing exercises.
Core strengthening protocol will comprise of following three phases:
1. Warm up phase
2. Core strengthening phase
3. Cool down phase
After performance of Core Strengthening protocol, group B will perform Resistive Diaphragmatic Exercises. Receives: Procedure: Core Strengthening; Procedure: Resistive-Diaphragm breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trunk flexor endurance test
Subject will sit on the test bench and place the upper body against a support with an angle of 60 ° from the test bed. The arms will be folded across the chest with the hands placed on the opposite shoulder. Subjects will be instructed to maintain the body position while the supporting wedge will be pulled back 10 cm to begin the test. The test will end when the upper body fell below the 60 ° angle.
Measured: 6 weeks
Change in trunk extensor endurance test
Subjects will be laid prone with the lower body fixed to the test bed at the ankles, knees, and hips and the upper body extended. Subjects will rest their upper bodies on the floor before the exertion. At the beginning of the exertion, the upper limbs will be held across the chest with the hands resting on the opposite shoulders, and the upper body will be lifted off the floor until the upper torso is horizontal to the floor. Subjects will be instructed to maintain the horizontal position as long as possible.
Measured: 6 weeks
Left lateral endurance test
The participants will assume a side-lying position with their legs fully extended and feet aligned on top of each other. Upon readiness, they will be instructed to transition into a full side-bridge position, ensuring that both legs remain extended and the sides of the feet are in contact with the floor. Timing will commence as they successfully maintain this position. The test will conclude if there is any noticeable change in the alignment of the participant's trunk. This test will be conducted twice with a 2-minute rest between intervals. The average duration of the two tests will be recorded on the participant's record sheet. The test will then
Measured: 6 weeks
Right lateral endurance test
The participants will assume a side-lying position with their legs fully extended and feet aligned on top of each other. Their lower arm will be positioned under their body while the upper arm rests at their side. Upon readiness, they will be instructed to transition into a full side-bridge position, ensuring that both legs remain extended and the sides of the feet are in contact with the floor. Timing will commence as they successfully maintain this position. The test will conclude if there is any noticeable change in the alignment of the participant's trunk. This test will be conducted twice with a 2-minute rest between intervals. The average duration of the two tests will be recorded on the participant's record sheet. The test will then
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Feb 2023
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Cross SyndromeStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172192
- Sponsor's protocol ID
- FUI/CTR/2023/23
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF CORE STRENGTHENING WITH RESISTIVE VERSUS NON-RESISTIVE DIAPHRAGMATIC TRAINING ON CORE ENDURANCE IN LOWER CROSS SYNDROME
- ClinicalTrials.gov ID
- NCT06172192
- Acronym / sponsor ID
- FUI/CTR/2023/23
- Conditions
- Lower Cross Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 15 Dec 2023 (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.
This study is a randomised control trial and the purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.
Detailed description
The purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.
Core stability of young adults (age: 19-30 years) will be determined using McGill's muscular endurance test battery:
- Flexor endurance test
- Extensor endurance test
- Right lateral endurance test
- Left lateral endurance test Scores will be taken three times for each test; the average of each text will be noted for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. McGill's Torso Muscular Endurance Test Battery will be used and baseline and post-intervention scores will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Core Strengthening, Procedure: Self-Diaphragm breathing exercisesGroup A will perform Core Strengthening exercises. In addition to core strengthening protocol, non-resistive Diaphragmatic training group will perform self-diaphragm breathing exercises Core strengthening protocol will comprise of following three phases: 1. Warm up phase: 2. Core strengthening phase: 3. Cool down phase: After performance of Core Strengthening protocol, Group A will perform Self-Diaphragmatic breathing exercises. |
| Group B | Experimental | Procedure: Core Strengthening, Procedure: Resistive-Diaphragm breathing exercisesGroup B will perform Core Strengthening exercises. In addition to core strengthening protocol, resistive Diaphragmatic training group will perform resisted-diaphragm breathing exercises. Core strengthening protocol will comprise of following three phases: 1. Warm up phase 2. Core strengthening phase 3. Cool down phase After performance of Core Strengthening protocol, group B will perform Resistive Diaphragmatic Exercises. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 19-30 years
- Both genders
- Positive modified Thomas test
- Positive prone hip extension strength test
- Positive trunk flexion strength test
Key exclusion criteria (12 listed)
- Shoulder pain
- Acute flare LBP
- Centralization and peripheralization of pain (21)
- Intermittent pain at limited end range (21)
- Leg symptoms when walking, eased in flexion (Signs of stenosis) (21)
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 |
|---|---|---|
| Core Strengthening1. Warm up phase Following exercise would be performed in warm up. Jump rope, Cross jacks, Standing side crunch, Mountain climbers, Scissor skier, Criss cross crunches, Reverse lunge high kick, Inchworm, Hip circles, Bent over. 2. Core Strengthening: Abdominal bracing, Bracing with heel slides, Bracing with leg lifts, Bracing with bridging, Bracing in standing, Bracing with standing row exercise, Quadruped arm lifts with bracing, Quadruped leg lifts with bracing, Quadruped alternate arm and leg lifts with bracing , Oblique abdominals 3. Cool down phase: Following exercise would be performed for cood down: child pose, Ab stretch, cat cow stretch, hip stretch, oblique stretch, standing forward bend. After performance of core strengthening protocol, group A will perform self-diaphragmatic breathing exercises while group B will perform resistive diaphragmatic breathing exercise. | Procedure or surgery | Group A, Group B |
| Self-Diaphragm breathing exercisesParticipants will place one hand on the chest and other on the abdomen, feeling the swelling of the stomach and the movement of the chest. It will be performed in supine position. Supervised breathing exercises in two sets for 15 minutes with 5 minutes break between sets and 10 minutes rest after it will be performed | Procedure or surgery | Group A |
| Resistive-Diaphragm breathing exercisesParticipants will place one hand on the chest and another on the sand bag placed over abdomen. This sand bag weighing 3-5 Kgs will provide resistance to breathing. These exercises will be performed in supine position. We will adjust the weight of the sandbag as per individual's level of 11-13 of 'Rating of Perceived Exercise (RPE)'. Supervised breathing exercises in two sets for 15 minutes with 5 minutes break between sets and 10 minutes rest after it will be performed | Procedure or surgery | Group B |
Primary outcome
Change in trunk flexor endurance test
Time frame: 6 weeks
Subject will sit on the test bench and place the upper body against a support with an angle of 60 ° from the test bed. The arms will be folded across the chest with the hands placed on the opposite shoulder. Subjects will be instructed to maintain the body position while the supporting wedge will be pulled back 10 cm to begin the test. The test will end when the upper body fell below the 60 ° angle.
Change in trunk extensor endurance test
Time frame: 6 weeks
Subjects will be laid prone with the lower body fixed to the test bed at the ankles, knees, and hips and the upper body extended. Subjects will rest their upper bodies on the floor before the exertion. At the beginning of the exertion, the upper limbs will be held across the chest with the hands resting on the opposite shoulders, and the upper body will be lifted off the floor until the upper torso is horizontal to the floor. Subjects will be instructed to maintain the horizontal position as long as possible.
Left lateral endurance test
Time frame: 6 weeks
The participants will assume a side-lying position with their legs fully extended and feet aligned on top of each other. Upon readiness, they will be instructed to transition into a full side-bridge position, ensuring that both legs remain extended and the sides of the feet are in contact with the floor. Timing will commence as they successfully maintain this position. The test will conclude if there is any noticeable change in the alignment of the participant's trunk. This test will be conducted twice with a 2-minute rest between intervals. The average duration of the two tests will be recorded on the participant's record sheet. The test will then
Right lateral endurance test
Time frame: 6 weeks
The participants will assume a side-lying position with their legs fully extended and feet aligned on top of each other. Their lower arm will be positioned under their body while the upper arm rests at their side. Upon readiness, they will be instructed to transition into a full side-bridge position, ensuring that both legs remain extended and the sides of the feet are in contact with the floor. Timing will commence as they successfully maintain this position. The test will conclude if there is any noticeable change in the alignment of the participant's trunk. This test will be conducted twice with a 2-minute rest between intervals. The average duration of the two tests will be recorded on the participant's record sheet. The test will then
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
Related trials for Lower Cross Syndrome
Not yet recruitingObservational study
Accuracy of AI in Positional Classification Between Lower Third Molar and Mandibular Canal
As a Decision-support Tool During Preoperative Assessment
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
Validation of Uzbek-Language ADAM, AMS, and IPSS Questionnaires in Men Aged 35-59 Years
Psychometric Validation of Men's Health Questionnaires
Active, not recruitingObservational study
Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian
Musculoskeletal Pain, Autonomy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Strengthening, Self-Diaphragm breathing exercises and Resistive-Diaphragm breathing exercises in people with Lower Cross Syndrome, run by Foundation University Islamabad at 1 site in Pakistan.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatima Aiman, MS-MSKPT* (0323-5495943, fatima.aiman966@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trunk flexor endurance test (time frame: 6 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 15 Dec 2023.