NCT04375163

Brief Summary

26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (MG) a sport massage was applied between the sets while in the control group (NMG) the break was passive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

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

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

July 9, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

April 29, 2020

Last Update Submit

July 8, 2020

Conditions

Keywords

sport massagedelayed onset muscle sorenessmuscles recoverycontinuous concentric eccentric exercise

Outcome Measures

Primary Outcomes (4)

  • Changes in Active Knee Range of Motion (ROM)

    The ROM of knee flexion and extension was measured before and after the exercise program application in both trials. In particular, the active knee extension was measured in the supine position and the active flexion in the prone position using a universal type goniometer.

    day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment

  • Changes in creatine kinase (CK) levels in blood plasma

    Blood samples were taken before and 24 hours after the isokinetic protocol to determine whether the exercise program caused fatigue and muscle damage. The blood sample was analyzed to determine CK activity levels in blood plasma using an in-vitro quantitative assay followed by a photometer

    day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment

  • Changes in thigh circumference

    The circumference of the thigh was measured with a tape measure before the test and after the exercise program at fixed spots at a distance of 10 and 20 cm from the center of the patella

    day 1: pre-treatment, after- treatment, day: 10 pre-treatment, after- treatment

  • Changes in Delayed Onset Muscle Soreness (DOMS)

    The DOMS measurement for the lower extremities (L-DOMS) was performed with the VAS scale 24, 48, 72 and 96 hours after the completion of the program. The VAS scale was tentative where 1 corresponded to "no soreness" and 10 to "very, very sore". The L-DOMS was assessed according to Doma et al1,22 and according to Jakeman et al, through questioning after they completed a body weight squat until their knees were flexed to approximately 90°

    day 1: 24, 48, 72 and 96 hours after-exercise, day 10: 24, 48, 72 and 96 hours after-exercise

Secondary Outcomes (1)

  • Changes in concentric and eccentric torque

    day 1: pre-treatment

Study Arms (2)

Massage group (ME)

EXPERIMENTAL

A sport massage was applied between the sets of an intense isokinetic exercise protocol for knee extensor muscles

Other: Isokinetic intense exercise protocolOther: Massage treatment

Control

ACTIVE COMPARATOR

the break between the sets of an intense isokinetic exercise protocol for knee extensor muscles was passive

Other: Isokinetic intense exercise protocol

Interventions

The isokinetic protocol included 6 sets of 10 maximum efforts at 60 °/s of one leg with a 2-minute break between the sets.

ControlMassage group (ME)

Massage consisted of stroking (30") and petrissage (50") for muscle relaxation, then friction (10"), pincement and clapping (30") to prepare muscles for the next set.

Massage group (ME)

Eligibility Criteria

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

You may qualify if:

  • Professional athletes
  • Age range between 18-25.

You may not qualify if:

  • Conduction of any strengthening exercises on the day before the tests
  • Musculoskeletal injury during the last six months
  • Background of knee trauma and/or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Education and Sports Sciences

Thessaloniki, Central Makedonia, 57001, Greece

Location

Study Officials

  • Evaggelos Sykaras

    Department of Physical Education and Sports Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor-blind randomized control trial. A masked assessor conducted the measurements.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (ME) a sport massage was applied between the sets while in the control group (NME) the break was passive. knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 5, 2020

Study Start

May 1, 2020

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

July 9, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations