NCT06303700

Brief Summary

To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

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

May 10, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

February 27, 2024

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • the severity of dyspnea

    Using a dyspnea 12 (D-12) questionnaire that assesses the severity of dyspnea using a rubric of the physical and emotional aspects of dyspnea.

    At the baseline evaluation

  • the level of fear of falling through daily life activities

    Using Fall efficacy scale (FES-I) questionnaire that assesses the level of fear of falling through daily life activities

    At the baseline evaluation

  • quality of life and public health

    Using the Short Form 36 (SF-36) questionnaire. The questionnaire was assigned to eight domains: physical functioning, role-functioning, bodily pain, general health, vitality, social functioning, and role-emotional and mental health

    At the baseline evaluation

Study Arms (3)

adolescents

from both sex, age ranged from twelve to seventeen years old, free from mobility disability and Severe cognitive impairment

youth

from both sex, age ranged from twenty to twenty-two years old, free from mobility disability and Severe cognitive impairment

geriatrics

from both sex, age ranged from sixty to eighty years old, free from mobility disability and Severe cognitive impairment

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All subjects were recruited from inhabitants of urban and rural areas in the Nile Delta Region, Egypt. They were assigned into 3 age-difference groups (adolescents, youth, and geriatrics).

You may qualify if:

  • The participants were male or female community-dwellers, They ranged in age: adolescents from 12 to 17 years old, youth from 20 to 22 years old, and geriatrics from 60 to 80 years old.

You may not qualify if:

  • subjects with mobility disabilities and severe cognitive impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated professor at faculty of physical therapy

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 12, 2024

Study Start

May 10, 2022

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations