Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics

March 28, 2023 updated by: Savvas Spanos, University of Thessaly

Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics in Two Functional Tests. Α Single-blinded Randomised Controlled Trial Protocol.

The primary aim of this randomized controlled trial is to investigate the effectiveness of 6 weeks of progressive resistance training (PRT) compared to neuromuscular training (NMT) on functional performance in healthy female participants as measured by the Single-Leg Landing (SLL) and Single-Leg Squat (SLS) tests.

The secondary aims are to investigate the,

  • change in abduction hip muscle strength, which will be measured with a Biodex System 3 Isokinetic Dynamometer. Outcomes will be measured at baseline and after 6 weeks of intervention.
  • adherence to the 6-week initial intervention (High adherence is defined as ≥ 80% attendance to the supervised interventions.)

Study Overview

Detailed Description

Participants will be randomized into two groups: PRT or NMT. Outcomes will be measured at baseline and after 6 weeks of intervention.

All sessions will be conducted in group sessions, with one researcher supervising the exercises. Patients receive education as well as supervised exercise from trained physiotherapists. Each session will last approximately 25-30 minutes. The duration of the program will be 6 weeks, with 3 sessions every week (total: 18 training sessions).

The NMT intervention sessions consist of a 5-minute submaximal warm-up followed by 25 minutes of NMT training with exercises focused on functional stability, proprioception, strength, stability, agility, postural function, and postural orientation. The training sessions will consist of two parts: warming up and the circuit program. The circuit program will consist of 8 exercises. Each exercise will be performed for 2 sets of 10 repetitions, with a rest of 30 sec corresponding to every set, between each set and exercises. The exercises will be focused on one knee, which will then be evaluated. Three levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by changing the exercise and gradually making it harder, or/and changing the support surface.

In the PRT intervention, the sessions will consist of a 5-minute submaximal warm-up followed by 20 minutes of PRT with exercises targeting the abductor muscles of the hip joint. The circuit program will consist of three exercises. Each exercise will be performed in sets of three, then increased to four sets of ten repetitions, with a 30-second rest between each set and exercise.

The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-10. The progression will be in line with guidelines provided by the American College of Sports Medicine.

Adherence to the program for both groups will be assessed by the total number of training sessions performed in 6 weeks (total = 18 training sessions).

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Central Greece
      • Lamia, Central Greece, Greece, GR-35132
        • University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female gender
  • older than 18 and younger than 35 years of age
  • physically able to perform physical activities and exercise
  • participants should know the greek language in order to understand the instructions and be able to read the consent form

Exclusion Criteria:

  • undergoing treatment for lower extremity injury
  • currently experiencing an average overall pain severity ≥3 out of 10 on an 11-point numerical rating scale in the past week
  • history of knee pain in the proceeding twelve months, history of lower limb surgery, known rheumatologic, neurological or cardiovascular disorders with raised blood pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular exercise training (NMT)

The 6-week exercise intervention consists of group sessions of Neuromuscular training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing.

Each session consists of a 5-minute submaximal warm-up followed by 25 minutes of NM training with closed kinetic chain exercises.

Every 2 weeks, there will be a progression that will be achieved by increasing the level of difficulty of each the exercise. We will take into consideration when an exercise is performed with appropriate sensorimotor control, quality of the performance, minimal exertion and control of the movement. Participants will be given special equipment including a step measuring 20 cm in height, an uneven surface, a slider and an elastic tubing medium load (green) from Thera BandTM, (Akron, Ohio, USA).

The 6-week exercise intervention consists of 25-minute group sessions of Neuromuscular training supervised by a researcher.
Experimental: Progressive Resistance Training (PRT)

The 6-week exercise intervention consists of group sessions of progressive resistance training supervised by a researcher 3 times per week. Participants will be familiarized with the exercises on a separate day prior to testing.

Each session consists of a 5-minute submaximal warm-up followed by 20 minutes of PRT with an open kinetic chain (no weight-bearing exercises) targeting the abductors' muscles of the hip joint. The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a Borg Rating of Perceived Exertion (RPE) of 6-8.

Every 2 weeks, there will be a progression achieved by changing the resistance in line with guidelines provided by the American College of Sports Medicine with an elastic tubing heavy load (grey) from Thera BandTM, (Akron, Ohio, USA)

The 6-week exercise intervention consists of of 20-minute group sessions of progressive resistance training, supervised by a researcher.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in knee kinematics measured during a Single-Leg Squat functional test
Time Frame: Measured at baseline and Week 6.
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Squat test. Changes during the test will be analyzed with the Kinovea program.
Measured at baseline and Week 6.
Changes in knee kinematics measured during a Single-Leg Landing functional test
Time Frame: Measured at baseline and Week 6.
Dynamic Knee Valgus (recorded in degrees) will be assessed during a Single-Leg Landing test. Changes during the test will be analyzed with the Kinovea program.
Measured at baseline and Week 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in abduction hip muscle power
Time Frame: Measured at baseline and Week 6.
Change in abduction hip muscle power (measured in Newtons) will be measured with a Biodex System 3 isokinetic dynamometer.
Measured at baseline and Week 6.
Adherence to the 6-week initial intervention
Time Frame: Measured at Week 6.
High adherence is defined as ≥ 80% attendance to the supervised interventions.
Measured at Week 6.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Actual)

March 21, 2023

Study Completion (Actual)

March 26, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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