NCT06070584

Brief Summary

forty quarry workers participated in the study with age range (40-60 years), body mass index (BMI) from 25 to 34.9 kg/m2 (over weight and class 1 obesity). The patients divided into two groups randomly. (Group A) received aerobic exercises (Group B) receive aerobic exercises with moderate intensity in the form of walking on electrical treadmill for 30 min and inspiratory muscle training for 10 minutes., 3 sessions per week for 8 consecutive weeks. Pulmonary function test was applied by spirometry to assess lung function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

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

January 2, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

September 24, 2023

Last Update Submit

November 5, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • adequate lung function

    Spirometer test, The patient was instructed to take a big breath in and then exhale as forcefully and quickly as they could, continuing until there was no more air remaining, in order to measure FVC and FEV1

    8 weeks

  • patient satisfaction

    VAS scoring, (no pain=0) and the other end (worst pain=10).

    8 weeks

Study Arms (2)

group A

ACTIVE COMPARATOR

received aerobic exercises only

Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,

Group B

EXPERIMENTAL

aerobic exercises with moderate intensity in the form of walking on electrical treadmill

Procedure: aerobic exercises with electrical treadmill for 30 min and inspiratory muscle training for 10 minutes.,

Interventions

aerobic exercises with moderate intensity in the form of walking on electrical treadmill

Group Bgroup A

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • quarry workers working in the quarries for five years ago at least saver from chest diseases\\\\
  • BMI ranged from 25 to 34.9 kg/cm2

You may not qualify if:

  • Subject with infected chest disease, unstable mental condition and chest cancer patients
  • musculoskeletal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2023

First Posted

October 6, 2023

Study Start

January 2, 2023

Primary Completion

May 2, 2023

Study Completion

October 2, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations