NCT03950596

Brief Summary

The aim of this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

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

First Submitted

Initial submission to the registry

May 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 1, 2019

Last Update Submit

May 13, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Genetic Changes in Knee Muscle and Tendon

    Comparison of results of genetic testing both before and after interventions between the 3 groups

    One year

  • Ultrasound Changes in Knee Muscle and Tendon

    Comparison of results of pre- and post ultrasound changes after interventions between the 3 groups

    One year

  • Biopsy Changes in Knee Muscle and Tendon

    Comparison of changes in biopsies taken before and after interventions between the 3 groups

    One year

Study Arms (3)

One acute resistance load exercise

ACTIVE COMPARATOR

One hundred volunteers will participate in one acute resistance load exercises to their quadriceps

Other: Acute resistant load exercisesBehavioral: Background QuestionnaireOther: Pain QuestionnaireGenetic: DNA and RNA testDiagnostic Test: UltrasoundDiagnostic Test: Percutaneous Needle Core Biopsy

Three acute resistance load exercises

ACTIVE COMPARATOR

One hundred volunteers will participate in three acute resistance load exercises to their quadriceps

Other: Acute resistant load exercisesBehavioral: Background QuestionnaireOther: Pain QuestionnaireGenetic: DNA and RNA testDiagnostic Test: UltrasoundDiagnostic Test: Percutaneous Needle Core Biopsy

Control Group

ACTIVE COMPARATOR

One hundred volunteers will participate in study as a control group

Behavioral: Background QuestionnaireOther: Pain QuestionnaireGenetic: DNA and RNA testDiagnostic Test: UltrasoundDiagnostic Test: Percutaneous Needle Core Biopsy

Interventions

Leg bench and leg press acute resistant load exercises Leg-bench and leg-press acute resistant load exercises

One acute resistance load exerciseThree acute resistance load exercises

Background questionnaire will be filled out by participants

Control GroupOne acute resistance load exerciseThree acute resistance load exercises

Pain questionnaire regarding pain in the knee during previous 3 months

Control GroupOne acute resistance load exerciseThree acute resistance load exercises

DNA and RNA tests will be sent to a genetic laboratory for analysis

Control GroupOne acute resistance load exerciseThree acute resistance load exercises
UltrasoundDIAGNOSTIC_TEST

Ultrasound of the knee joint and the quadriceps muscle and the pica tendon

Control GroupOne acute resistance load exerciseThree acute resistance load exercises

Core Biopsy will be taken from the quadriceps femoris muscle

Control GroupOne acute resistance load exerciseThree acute resistance load exercises

Eligibility Criteria

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

You may qualify if:

  • Non-professional athletes
  • Pass heart/lung endurance tests
  • Pass ergometrics testing

You may not qualify if:

  • Have been injured
  • Had physiotherapy for back or lower limbs in past 6 months
  • Orthopedic surgery in lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

DNAUltrasonography

Intervention Hierarchy (Ancestors)

Nucleic AcidsNucleic Acids, Nucleotides, and NucleosidesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 15, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations