NCT05023876

Brief Summary

The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization applied to the hamstring muscle on respiratory function in patients with COPDThe patients to be included in the study will be divided into two groups by simple randomization. A group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and thoracic expansion exercises) as a home program. The other group will be given breathing exercises in the form of a home program in addition to 1 session of EDYM per week. Both groups will be evaluated before and 4 weeks after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

August 21, 2021

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory Function

    Respiratory Function evaluated with spirometer

    5 minute

Secondary Outcomes (5)

  • Chest circumference measurement

    5 minute

  • Popliteal angle test

    3 minutes

  • Finger-floor distance measurement

    3 minutes

  • Hand grip strength

    3 minutes

  • 6-minute walk test

    6 minute

Study Arms (2)

IASTM group

EXPERIMENTAL
Other: Respiratory Exercise

Control Group

EXPERIMENTAL
Other: IASTM+respiratory Exercise

Interventions

Instrument assisted soft tissue mobilization

Control Group

Respiratory Exercise

IASTM group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with GOLD stage I-II COPD
  • Between the ages of 40-65
  • COPD in stable period
  • No other respiratory disease that impairs respiratory functions such as asthma
  • Knee flexion angle of 15 degrees and above in the hamstring muscle shortness test,
  • Individuals without musculoskeletal problems in their lower extremities were included.

You may not qualify if:

  • COPD patients who receive home oxygen therapy or who need oxygen therapy frequently
  • COPD exacerbation, hospitalization with acute exacerbation in the last 15 days
  • Pregnancy
  • Kyphoscoliosis, advanced postural disorder
  • Prior thoracic surgery
  • Advanced heart failure
  • Patients with primary pulmonary hypertension or have had a pulmonary embolism,
  • Having serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
  • Neuromuscular disease
  • Having dementia, Alzheimer's or advanced cognitive problems,
  • Diagnosed with lung cancer or other malignancy,
  • People with morbid obesity will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2021

First Posted

August 27, 2021

Study Start

March 14, 2022

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations