NCT05695482

Brief Summary

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.)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

January 10, 2023

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in knee kinematics measured during a Single-Leg Squat functional test

    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

    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 Outcomes (2)

  • Change in abduction hip muscle power

    Measured at baseline and Week 6.

  • Adherence to the 6-week initial intervention

    Measured at Week 6.

Study Arms (2)

Neuromuscular exercise training (NMT)

EXPERIMENTAL

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).

Other: Neuromuscular training exercises

Progressive Resistance Training (PRT)

EXPERIMENTAL

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)

Other: Hip abductors muscular strength exercises

Interventions

The 6-week exercise intervention consists of 25-minute group sessions of Neuromuscular training supervised by a researcher.

Neuromuscular exercise training (NMT)

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

Progressive Resistance Training (PRT)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamia, Central Greece, GR-35132, Greece

Location

Related Publications (9)

  • Kraemer WJ, Adams K, Cafarelli E, Dudley GA, Dooly C, Feigenbaum MS, Fleck SJ, Franklin B, Fry AC, Hoffman JR, Newton RU, Potteiger J, Stone MH, Ratamess NA, Triplett-McBride T; American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2002 Feb;34(2):364-80. doi: 10.1097/00005768-200202000-00027.

    PMID: 11828249BACKGROUND
  • Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.

    PMID: 25390299BACKGROUND
  • Day ML, McGuigan MR, Brice G, Foster C. Monitoring exercise intensity during resistance training using the session RPE scale. J Strength Cond Res. 2004 May;18(2):353-8. doi: 10.1519/R-13113.1.

    PMID: 15142026BACKGROUND
  • Peixoto Leao Almeida G, Oliveira Monteiro I, Larissa Azevedo Tavares M, Lourinho Sales Porto P, Rocha Albano T, Pasqual Marques A. Hip abductor versus adductor strengthening for clinical outcomes in knee symptomatic osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2022 Oct;61:102575. doi: 10.1016/j.msksp.2022.102575. Epub 2022 May 13.

    PMID: 35780637BACKGROUND
  • Horsak B, Artner D, Baca A, Pobatschnig B, Greber-Platzer S, Nehrer S, Wondrasch B. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial. Trials. 2015 Dec 23;16:586. doi: 10.1186/s13063-015-1091-5.

    PMID: 26700568BACKGROUND
  • Bennell KL, Kyriakides M, Metcalf B, Egerton T, Wrigley TV, Hodges PW, Hunt MA, Roos EM, Forbes A, Ageberg E, Hinman RS. Neuromuscular versus quadriceps strengthening exercise in patients with medial knee osteoarthritis and varus malalignment: a randomized controlled trial. Arthritis Rheumatol. 2014 Apr;66(4):950-9. doi: 10.1002/art.38317.

    PMID: 24757146BACKGROUND
  • Clausen B, Holsgaard-Larsen A, Roos EM. An 8-Week Neuromuscular Exercise Program for Patients With Mild to Moderate Knee Osteoarthritis: A Case Series Drawn From a Registered Clinical Trial. J Athl Train. 2017 Jun 2;52(6):592-605. doi: 10.4085/1062-6050-52.5.06.

    PMID: 28653869BACKGROUND
  • Stefanouli V, Kapreli E, Anastasiadi E, Nakastsis A, Strimpakos N. Validity and reliability of the Greek version of modified Baecke questionnaire. Public Health. 2022 Feb;203:58-64. doi: 10.1016/j.puhe.2021.11.017. Epub 2022 Jan 13.

    PMID: 35032916BACKGROUND
  • Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.

    PMID: 25935843BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Human Performance and Rehabilitation Laboratory of the Physiotherapy Department

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 25, 2023

Study Start

February 7, 2023

Primary Completion

March 21, 2023

Study Completion

March 26, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations