NCT06252896

Brief Summary

The aim of this study is to evaluate the effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on the acute effects of physical fitness parameters in healthy male individuals. 24 volunteers are included in this study who have been divided into two groups such that one part is an IASTM and the other part is a control group. The physical activity levels of the individuals participating in the study were determined using the short form of the International Physical Activity Assessment Questionnaire (IPAQ). Individuals; their aerobic capacity is the Incremental Shuttle Walk Test (ISWT), muscle strength values are digital dynamometer, muscle flexibility values are sit-reach and quadriceps flexibility test, fatigue values are Fatigue Severity Scale (FSS) and Modified Borg Scale, agility assessment is T-Test, and balance assessment is evaluated with a stabilometer device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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

March 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 12, 2024

Last Update Submit

February 1, 2024

Conditions

Keywords

Aerobic AgilityBalanceCapacityFatigueFlexibilityMobilization

Outcome Measures

Primary Outcomes (1)

  • Flexibility

    Hamstring flexibility measurements of the individuals were performed with a sit-and-reach test using a flexibility bench. Quadriceps flexibility was assessed by placing both hips in a neutral position while the subject lay in the prone position.

    up to six week

Secondary Outcomes (5)

  • Exercise Capacity

    up to six week

  • Agility

    up to six week

  • Balance

    up to six week

  • Muscle Strength

    up to six week

  • Fatique

    up to six week

Study Arms (2)

IASTM Group

EXPERIMENTAL

Individuals were positioned on the stretcher so that the area to be applied was exposed. ADYDM to be applied to ensure comfortable movement of the instrument on the tissue before application baby oil was applied to cover the area. In order to increase the effectiveness of the application suggestions were made to the person to relax. Application ADYDM for each muscle group tool (Figure 3.4) for 5 minutes. The occurrence of allergic reactions on the skin the test was terminated.

Other: INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE

Control Group

PLACEBO COMPARATOR

The control group was kept for 30 minutes without ADYDM application and then muscle strength assessment, flexibility assessment, agility assessment, balance assessment and finally aerobic capacity assessment were performed respectively.

Other: NO INTERVENTION

Interventions

After all evaluations were made, IASTM was applied to the individuals in the intervention group for five minutes each, for a total of 20 minutes, on the quadriceps and hamstring muscles of both extremities, respectively.

IASTM Group

The control group waited for 30 minutes after the initial measurements and all measurements were repeated.

Control Group

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age range between 18-25 years,
  • Individuals who volunteered to participate in the study were included.

You may not qualify if:

  • Those with diagnosed cardiopulmonary, neurological, orthopedic, psychiatric, skin disease and vestibular diseases,
  • Those who have had an acute infection in the last fifteen days
  • Individuals who showed and/or were at risk of allergic reactions during ADYDM application were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Kocasinan/Kayseri, 38090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-Investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 12, 2024

Study Start

March 22, 2022

Primary Completion

May 30, 2022

Study Completion

July 27, 2022

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations