NCT04357743

Brief Summary

Randomized control Trial, Purposive sampling was used to obtain the sample for the study and then randomly allocated into groups by coin toss method. Data collected from July 2019 to January 2020, was conducted at Rehman Medical Institute Peshawar. To determine the effects of pursed lip breathing with arm ergometry after chin support position on heart rate, respiratory parameters, pulmonary function tests and quality of life in COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

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

Study Start

First participant enrolled

April 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

COPD

Keywords

Arm ErgometryChin Support PositionOxygen Saturation

Outcome Measures

Primary Outcomes (6)

  • Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    1 week

  • Forced vital Capacity (FVC)

    Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters.

    1 week

  • Peak Expiratory Flow (PEF)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.

    1 week

  • Oxygen Saturation (SpO2)

    Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.

    1 week

  • Pulse Rate/Heart Rate

    Changes from the Baseline, It is the speed of Pulse/heart contractions per minute. It is measured by pulse oximeter

    1 week

  • Modified Borg Scale of Perceived Exertion

    Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.

    1 week

Secondary Outcomes (1)

  • COPD Assessment Tool (CAT)

    1 week

Study Arms (2)

Chin supported Arm ergometry with pursed lip breathing

EXPERIMENTAL

Chin supported along with Arm ergometry with pursed lip breathing

Other: Chin supported Arm ergometry with pursed lip breathing

Arm ergometry with pursed lip breathing

ACTIVE COMPARATOR

Arm ergometry with pursed lip breathing

Other: Arm ergometry with pursed lip breathing

Interventions

Chin supported Arm ergometry with pursed lip breathingOTHER

The participants sat in chin support position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes. The participants again sat in chin support position for 10 minutes. The treatment was provided for one week

Chin supported Arm ergometry with pursed lip breathing
Arm ergometry with pursed lip breathingOTHER

The participants sat in normal position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes; the participants again sat in sitting position for 10 minutes. The treatment was provided for one week.

Arm ergometry with pursed lip breathing

Eligibility Criteria

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

You may qualify if:

  • Mild to moderate stage COPD according to GOLD criteria {i-e Global Initiative for Obstructive Lung Disease (GOLD) }

You may not qualify if:

  • COPD patient with angina pectoris,
  • third degree heart block,
  • congestive heart failure and
  • orthopedic or neuromuscular conditions (cervical involvement which aggravate symptoms) or radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pulmonology of Rehman medical Institute.

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (7)

  • Tunkamnerdthai O, Auvichayapat P, Punjaruk W, Manimmanakorn A, Leelayuwat N, Boonsawat W, et al. Modified Arm Swing Exercise Improves Oxidative Stress and Heart Rate Variability in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Journal of Exercise Physiology Online. 2018;21(4)

    BACKGROUND

  • Halldin CN, Doney BC, Hnizdo E. Changes in prevalence of chronic obstructive pulmonary disease and asthma in the US population and associated risk factors. Chron Respir Dis. 2015 Feb;12(1):47-60. doi: 10.1177/1479972314562409. Epub 2014 Dec 24.

    PMID: 25540134BACKGROUND

  • Ntritsos G, Franek J, Belbasis L, Christou MA, Markozannes G, Altman P, Fogel R, Sayre T, Ntzani EE, Evangelou E. Gender-specific estimates of COPD prevalence: a systematic review and meta-analysis. Int J Chron Obstruct Pulmon Dis. 2018 May 10;13:1507-1514. doi: 10.2147/COPD.S146390. eCollection 2018.

    PMID: 29785100BACKGROUND

  • Mesquita Montes A, Maia J, Crasto C, de Melo CA, Carvalho P, Santos R, Pereira S, Vilas-Boas JP. Abdominal muscle activity during breathing in different postures in COPD "Stage 0" and healthy subjects. Respir Physiol Neurobiol. 2017 Apr;238:14-22. doi: 10.1016/j.resp.2017.01.001. Epub 2017 Jan 7.

    PMID: 28082171BACKGROUND

  • Xu J, He S, Han Y, Pan J, Cao L. Effects of modified pulmonary rehabilitation on patients with moderate to severe chronic obstructive pulmonary disease: A randomized controlled trail. Int J Nurs Sci. 2017 Jun 27;4(3):219-224. doi: 10.1016/j.ijnss.2017.06.011. eCollection 2017 Jul 10.

    PMID: 31406744BACKGROUND

  • McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.

    PMID: 25705944BACKGROUND

  • Bharadwaj TA, Jiandani MP, Mehta A. PURSED LIP BREATHING INCREASES UNSUPPORTED UPPER EXTREMITY EXERCISE ENDURANCE AND REDUCES DESATURATION IN COPD. Romanian Journal of Physical Therapy/Revista Romana de Kinetoterapie. 2016;21(38).

    BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Iqbal Tariq, MsCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 22, 2020

Study Start

April 1, 2019

Primary Completion

January 10, 2020

Study Completion

February 10, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)