NCT05934240

Brief Summary

Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. The potential positive effects of thoracic manipulation on respiratory system diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been investigated and continue to be studied. Specifically, the results of studies investigating the physiological outcomes of this therapeutic approach in healthy adults are conflicting. The aim of this study is to investigate the short-term effects of thoracic manipulation and mobilization, as well as diaphragm mobilization, through a single session of manual therapy interventions on respiratory functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

29 days

First QC Date

June 21, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

Manual therapyRespiratory function testPhysical activity

Outcome Measures

Primary Outcomes (3)

  • Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)

    The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.

    Change from before and 5 minutes after application

  • Pulmonary Functions Test-FVC (Forced vital capacity)

    Forced vital capacity, the maximum amount of air you can forcibly exhale from your lungs after fully inhaling.

    Change from before and 5 minutes after application

  • Pulmonary Functions Test- FEV1/FVC

    The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.

    Change from before and 5 minutes after application

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Diaphragmatic mobilization, toracic mobilization and manipulation

Other: Manual therapy group

Control group

PLACEBO COMPARATOR

Placebo mobilization and manipulation

Other: Sham-manual therapy

Interventions

Manual therapy will be applied to the diaphragm and thoracic region.

Experimental group

Sham-manual therapy will be applied to the diaphragm and thoracic region.

Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be between the ages of 18-25,
  • to be a studen

You may not qualify if:

  • those who have any health problems
  • those with orthopedic disorders
  • those with systemic and cardiopulmonary diseases that would interfere with the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (1)

  • Kucuk E, Tozcu D, Topaktas B, Coskun G. Immediate effects of manual therapy on respiratory functions in healthy young individuals: a randomized controlled trial. Sci Rep. 2024 Jul 29;14(1):17419. doi: 10.1038/s41598-024-68654-7.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 6, 2023

Study Start

July 1, 2023

Primary Completion

July 30, 2023

Study Completion

August 15, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations