NCT03769480

Brief Summary

To investigate the relationship between respiratory function and core muscles strength in athletes with disabilities and compare with healthy athletes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

November 29, 2018

Last Update Submit

December 7, 2018

Conditions

Keywords

AthletesDisabilityRespiratory FunctionCore MusclesSport

Outcome Measures

Primary Outcomes (6)

  • FVC (the rate of normal value by the spirometer device)

    Functional vital capacity: will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)

    2 days

  • FEV1 ( the rate of normal value by the spirometer device)

    First second Forced Expiratory Volume:will evaluate by the rate of normal value by the spirometer device (Pony FX Cosmed device)

    2 days

  • Muscle strength (Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)

    Abdominal Flexor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).

    2 days

  • Muscle strength (Abdominal Exstansor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)

    Abdominal Extensor Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).

    2 days

  • Muscle strength (Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)

    Abdominal right rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).

    2 days

  • Muscle strength (Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device)

    Abdominal left rotator Muscle Strength: will evaluate as Newtonmeter (Nm) by isokinetic device (IsoMed 2000, trunk attachment).

    2 days

Study Arms (2)

Study Group

Study Group=Athletes with Disability

Other: Muscle strength evaluation and Respiratory function Tests

Control Group

Control Group=Healthy Athletes

Other: Muscle strength evaluation and Respiratory function Tests

Interventions

Muscle strength evaluation and Respiratory function Tests

Control GroupStudy Group

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

The study group is Athletes with disabilities. The control group is the same sport branches but healthy athletes without any disabilites

You may qualify if:

  • Being professional athletes for at least three years.

You may not qualify if:

  • Having any lumbar injuries in the last three months,
  • Having systemic problems other than their disabilities(for athletes with disabilities),
  • Having any disability related to vision and hearing,
  • Acute or chronic respiratory infection,
  • Spinal cord injury level up to the innervation of the abdominal muscles (for paraplegic athletes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bihter Akınoğlu

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • Tuğba Kocahan, Dr

    The Ministry of Youth and Sports, Sports General Directorship, Ankara, Turkey

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 7, 2018

Study Start

November 1, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

December 10, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

The participants all is national team. Because we can not share the data

Locations