NCT06172192

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

February 15, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2024

Completed
Last Updated

December 15, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

December 7, 2023

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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

    6 weeks

Study Arms (2)

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.

Procedure: Core StrengtheningProcedure: 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.

Procedure: Core StrengtheningProcedure: Resistive-Diaphragm breathing exercises

Interventions

1. 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.

Group AGroup B

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

Group A

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

Group B

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19-30 years
  • Both genders
  • Positive modified Thomas test
  • Positive prone hip extension strength test
  • Positive trunk flexion strength test
  • Tight erector spinae
  • 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

You may not qualify if:

  • 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)
  • Paresthesia/numbness (21)
  • Structural deformity (Kyphosis, lordosis, scoliosis, spondylosis, spondylolysis, spondylolisthesis)
  • Curve reversal (21)
  • Pregnancy
  • Post surgery
  • Degenerative and inflammatory spinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Central Study Contacts

Fatima Aiman, MS-MSKPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 15, 2023

Study Start

February 15, 2023

Primary Completion

December 20, 2023

Study Completion

January 20, 2024

Last Updated

December 15, 2023

Record last verified: 2023-11

Locations