NCT05236244

Brief Summary

The research will be the first to examine the relationship between mental fatigue induced by motor imagery and upper extremity performance. This study, it is aimed to examine whether the effects of mental fatigue created by motor imagery on upper extremity performance can be reduced by diaphragmatic breathing exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

February 2, 2022

Last Update Submit

October 12, 2023

Conditions

Keywords

motor imagerymental fatiguediaphragmatic breathing exercises

Outcome Measures

Primary Outcomes (9)

  • 1-Isometric Elbow Flexion Force

    1-Isometric Elbow Flexion Force: The participant will try to move their hands towards their shoulder as forcefully as possible for 2-3 seconds with their upper arms at their sides, elbow bent at 90 degrees and forearm in supination.

    8 weeks

  • 2-Handgrip strength

    2-Handgrip strength: Handgrip strength will be assessed using a Jamar hand dynamometer (Lafayette Instrument Company, USA).

    8 weeks

  • 3-Upper extremity reaction test

    3-Upper extremity reaction test: It is planned to use a validated BlazePod sensor for upper extremity reaction time test

    8 weeks

  • 4-Finger reaction test

    4-Finger reaction test: By placing the dominant hand index finger on the left button of a computer mouse, the participant will be asked to press the left button as soon as the traffic light pattern glows green on the screen.

    8 weeks

  • 5-Hand performance test

    5-Hand performance test: A nine-hole peg test will be used.

    8 weeks

  • 6-Position Sense

    6-Position Sense: The height of the laser track marker test target board can be adjusted according to the height of the person, and the zero point will be aligned for each patient's glenohumeral joint separately. A standardized coordinate system drawn on the target board will show the different angles of motion calculated using a formula.

    8 weeks

  • 7-Tactile sense

    7-Tactile sense: The calibrated Semmes Weinstein monofilament test (North Coast Medical, USA) will be used to measure perceptual thresholds for cutaneous stimuli (Bell-Krotoski, Fess, Figarola, \& Hiltz, 1995; Dannenbaum, Michaelsen, Desrosiers, \& Levin, 2002).

    8 weeks

  • 8-Two-point discrimination

    8-Two-point discrimination: The two-point discrimination test is the evaluation of the ability to detect stimuli applied from two different points at the same time.

    8 weeks

  • 9-Upper extremity endurance test

    9-Upper extremity endurance test: After weighing the body weight, the weight to be held in the hand will be calculated as 2% of the body weight and if it is fractional, it will be rounded to the nearest 0.5 kg. The participant will hang the test arm out of the bed. Here he has to take the weight in his hand and raise it so that the "thumb faces up" and the arm is 90° horizontally. A metronome set to 60 Hz will then be used to standardize the test; in this way, participants will be instructed to raise their arms at the first beep, to keep the arm in 90 abduction during the next beep, and then to lower them to the starting position with the third beep. The test will be terminated as a result of fulfilling any of the following termination criteria (Moore, Uhl, \& Kibler, 2013).

    8 weeks

Secondary Outcomes (1)

  • Mental Fatigue (VAS)

    8 weeks

Study Arms (2)

İntervention group

EXPERIMENTAL

Diaphragmatic breathing exercises: First Evaluation + (1 week break) + Motor imagery protocol + Second Evaluation + 8 weeks of diaphragmatic breathing exercises +Third Evaluation +(1 week interval) + Motor imagery protocol + Fourth Evaluation

Other: İntervention group

Control Group

NO INTERVENTION

First Evaluation + (1 week break) + Motor imagery protocol + Second Evaluation + 8 weeks break +Third Evaluation +(1 week interval) + Motor imagery protocol + Fourth Evaluation

Interventions

Diaphragmatic Breathing Exercises

İntervention group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right-handed dominance (it will be decided according to Edinburgh Hand Questionnaire Result)
  • Volunteer to participate in the study.
  • To be sedentary
  • Not having any problems that prevent breathing exercises
  • Be between the ages of 18-30

You may not qualify if:

  • Have any mental or sensory problems in the past 6 months
  • Presence of acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc.
  • Having had Covid-19
  • Having any respiratory disease (asthma, COPD, etc.)
  • Having any upper extremity injury and/or operation (trauma, surgery, fracture, etc.) in the -Last 6 months doing regular exercises (at least 30 minutes a day / 5 times a week for a total of at least 150 minutes)
  • Be on regular medication
  • Be smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BandırmaOnyediEylulU

Balıkesir, 10200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

March 1, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations