NCT04553315

Brief Summary

the study attempted to assess and evaluate the efficacy of implementing chest expansion exercises on patients with pleural effusion and how this programme contribute to reduce pulmonary infection and complications. To address the objective of the study, the researcher utilized chest expansion exercises consisted of stacked breathing exercise, segmental breathing, chest mobility exercises, deep breathing exercise with use of incentve spirometer and assess the patient before and after exercises by using three tools help to monitor hemodynamic parameters, chest condition, laboratory investigations which help to evaluate pulmonary infection score and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 30, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

August 30, 2020

Last Update Submit

September 30, 2020

Conditions

Keywords

Chest expansion exercisescomplicationspleural effusionpulmonary infection

Outcome Measures

Primary Outcomes (2)

  • score of pulmonary infection

    through the study pulmonary infection will be assessed by using pulmonary infection score by assessing parameters as WBCs, temperature and chest condition

    1 year

  • rate of complications

    complications will be assessed through the study by using evaluation outcomes tool

    1 year

Study Arms (2)

intervention group

EXPERIMENTAL

Intervention group was received Chest mobility exercises with Incentive spirometer and segmental breathing exercise and breath stacking technique . The patient in the intervention group was instructed to perform the exercises 3 times per day, 7-8 times per session for one week. Ensure that the patient fully hydrated by maintaining normal daily water requirement in the form of (30-35ml/kg/day) with restriction of intravenous fluids.

Procedure: chest expansion exercises

control group

EXPERIMENTAL

control group will receive only routine hospital care

Procedure: chest expansion exercises

Interventions

Chest mobility exercises with Incentive spirometer and segmental breathing exercise ) and breath stacking technique e.

control groupintervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 18 - 60 years.
  • patients of both genders.
  • patients diagnosed as pleural effusion by the physician.
  • patients with asymmetrical chest expansion.

You may not qualify if:

  • Orthopedic conditions.
  • Pleural effusion due to transudate conditions like: liver cirrhosis, …. etc.
  • Malignant conditions.
  • Cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Asyut, Egypt

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Amal A Mohamed

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: implementing chest expansion exercises on patient with pleural effusion to evaluate its efficacy on preventing pulmonary infection and complications
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 30, 2020

First Posted

September 17, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 30, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

no plan to share IPD

Locations