NCT06621667

Brief Summary

kyphotic subjects have respiratory disturbances due to weakening of the diaphragm, responsible for inhalation, which lead to abnormalities in respiratory mechanics and abnormal gas exchange, leading to respiratory complications. Myofascial release of the diaphragm is an intervention intended to indirectly stretch the diaphragm muscle fibers to reduce muscle tension, normalize fiber length, and promote the efficiency of muscle contraction. Although diaphragm myofascial release has been used in clinical practice, to the best of the authors' knowledge, the current study is the first research investigating the effect of diaphragmatic myofascial release on lung function, chest mobility and kyphotic curve in hyperkyphotic subjects.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

September 29, 2024

Last Update Submit

September 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • maximum voluntary ventilation

    the maximum voluntary ventilation will be measured using spirometer

    change from base line at 4 weeks.

Secondary Outcomes (2)

  • Chest expansion

    change from base line at 4 weeks.

  • kyphotic angle

    change from base line at 4 weeks.

Study Arms (2)

study group

EXPERIMENTAL
Other: diaphragmatic myofascial release with traditional physical therapy exercises for hyperkyphosis

control group

ACTIVE COMPARATOR
Other: traditional physical therapy exercises for hyperkyphosis

Interventions

traditional physical therapy exercises for hyperkyphosis

control group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The participant's age ranged from 20 to 40 years.
  • kyphosis angle 40-50◦
  • reporting pain on palpation of the diaphragm

You may not qualify if:

  • A history of respiratory diseases, heart disease, vascular disease, central nervous system disorder, psychiatric disorders, hypertension.
  • History of any trauma or fracture to the thoracic spine.
  • inflammatory diseases such as rheumatoid arthritis, musculoskeletal problem and neurological deficit
  • Restrictive respiratory disease, smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 1, 2024

Study Start

October 10, 2024

Primary Completion

December 20, 2024

Study Completion

December 30, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09