Clinical trial NCT05695482: Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics
Official title: Progressive Resistance Training Compared to Neuromuscular Exercises on Knee Kinematics in Two Functional Tests. Α Single-blinded Randomised Controlled Trial Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dynamic Knee Valgus
Injury Prevention
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in knee kinematics measured during a Single-Leg Squat functional test
timeFrame: Measured at baseline and Week 6.
measure: Changes in knee kinematics measured during a Single-Leg Landing functional test
timeFrame: Measured at baseline and Week 6.
Secondary outcomes:
measure: Change in abduction hip muscle power
timeFrame: Measured at baseline and Week 6.
measure: Adherence to the 6-week initial intervention
timeFrame: Measured at Week 6.
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
state: Central Greece
Study officials:
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