NCT04255355

Brief Summary

The goal of this research study is to compare the effects of pelvic alignment versus diaphragmatic breathing on range of motion in the shoulder joint in both athletic and nonathletic population. The investigators plan to have approximately 45 participants to take part in this study. Subjects will be assigned into three groups. Group 1 will perform both pelvic alignment and diaphragmatic breathing exercises. This group will be used as the standard or control group. Group 2 will perform pelvic alignment exercise only; and Group 3 will perform diaphragmatic exercises only. The shoulder internal rotation range will be assessed in all three groups. Maximal expiratory rate will be measured in group 3 to assure improved diaphragmatic breathing in subjects. The shoulder internal rotation range in group 2 \& 3 will be compared to the shoulder range of motion in the standard group.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

January 29, 2020

Last Update Submit

March 30, 2020

Conditions

Keywords

ShoulderPelvisRegional interdependenceDiaphragm

Outcome Measures

Primary Outcomes (2)

  • Changes in shoulder internal rotation rang of motion

    A Cybex isokinetic table will be used for standard positioning of the participants's arm. the participant will be positioned in supine, with his/her arm supported on the dynamometer's arm for shoulder assessment. Shoulder internal rotation range of motion will be assessed using the digital goniometer incorporated into the cybex dynamometer.

    Change from baseline internal rotation range of motion after 5 days of intervention

  • Changes in Maximal expiratory rate

    A digital spirometer (EasyOne Plus Diagnostic Spirometry System) will be use for assessing maximal expiratory rate. A maximal expiratory test will be performed with the subject in sitting. A nose clip will be used to ensure all air is going into the manometer. Our measurements will be taken from total lung capacity, so the subject will first fully inhale, then fully exhale, pausing for 1-2 seconds at the end.

    Change from baseline expiratory rate after 5 days of intervention

Secondary Outcomes (1)

  • Change in pelvic alignment

    Change from baseline hip adduction range of motion after 5 days of interventjion

Study Arms (3)

Pelvic alignment and forceful expiration exercise

ACTIVE COMPARATOR
Other: Pelvic alignment and forceful expiration

Pelvic repositioning exercise

EXPERIMENTAL
Other: Pelvic repositioning exercise

Diaphragmatic breathing exercise

EXPERIMENTAL
Other: Diaphragmatic breathing exercise

Interventions

The participant will be in supine with feet flat on a wall and the knees and hips flexed to 90 degrees. A standard 5" ball will be placed between the knees. The participant will hold a standard 9-inch balloon in the mouth with one hand. The subject will be instructed to isometrically contract the hamstrings to lift the ischium off the table while maintaining a posterior pelvic tilt. In this position, subject will be instructed to perform isometric hip adduction by squeezing the ball placed between the knees. The subject will then be instructed to breathe in through the nose and blow the air out into the balloon with full exhalation to activate the transverse and oblique abdominals. The participant will hold the breath for 3 seconds while maintaining hamstring contraction, adductor contraction, and transverse and oblique abdominal contraction. This process will be repeated four times. This exercise will be performed once daily under the supervision of the therapist for 5 days.

Pelvic alignment and forceful expiration exercise

The participant will be positioned supine with their feet flat on a wall and the knees and hips flexed to 90 degrees. The subject will be instructed to isometrically contract the hamstrings to allow the ischial tuberosities to lift off the table while also maintaining a posterior pelvic tilt. The tailbone should be slightly lifted off the table, the abdominal muscles should be relaxed, and the low back should be flat on the table. While maintaining the posterior pelvic tilt, the subject will be instructed to perform isometric hip adduction by squeezing the ball that is placed between the knees. The subject will hold for 3 seconds and then relax. This process will be repeated four times. This exercise will be performed daily under the supervision of the therapist for 5 days.

Pelvic repositioning exercise

For diaphragmatic breathing exercise, the subject will be in supine position. The investigator places both hands around the participant's lower ribs and abdominal area. The investigator applies slight manual resistance to the chest and abdominal wall during inhalation phase of breathing.The participant is instructed to apply outward pressure against the investigator resistance and to raise the chest and abdominal wall simultaneously with inhalation. Then participants performs a full exhalation and hold his/her breath for 3 seconds before breathing in again. This process is repeated for 4 breathing cycles. Participants will perform this exercise once a day under investigator supervision.

Diaphragmatic breathing exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a unilateral positive Ober's test
  • Having reduced (more than 15 degrees) shoulder internal rotation in the contralateral shoulder

You may not qualify if:

  • Having a positive Craig's test
  • Having bilateral positive Ober's test
  • Structural leg length discrepancies
  • Having shoulder pain, back pain or any other musculoskeletal pain or dysfunctions
  • Having any other medical conditions that prevents them from performing physical exercise
  • Having any respiratory or other medical conditions that prevents them from performing deep breathing and expiratory exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Georgia

Dahlonega, Georgia, 30597, United States

Location

Study Officials

  • Mohammad R Nourbakhsh, PhD

    University of North Georgia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Nourbakhsh, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 5, 2020

Study Start

July 30, 2020

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After the results have been published

Locations