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Clinical Trials/NCT07271173
NCT07271173
Completed
Not Applicable

Study on the Effects of Unilateral Resistance Training on Lower Limb Muscle Strength and Symmetry After Anterior Cruciate Ligament Reconstruction Surgery

Peking University Third Hospital1 site in 1 country48 target enrollmentStarted: April 6, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
muscle strength

Overview

Brief Summary

Brief Summary Study type: Randomized controlled trial (interventional). Purpose: To find out whether six weeks of unilateral resistance training (URT) improves lower-limb strength and inter-limb symmetry more than traditional bilateral resistance training (BRT) after anterior cruciate ligament reconstruction (ACLR).

Main questions:

Does URT produce better limb-symmetry in knee flexor/extensor peak torque than BRT? Does URT lead to larger gains in feed-forward motor control, Lysholm knee score and International Knee Documentation Committee 2000 (IKDC 2000) subjective rating? Comparison: Participants will be randomly assigned to URT (each exercise done one leg at a time) or BRT (both legs work together). Training volume, frequency, session length and progression rules are identical in both groups.

What participants will do: After giving consent, complete baseline tests of strength, motor control and knee questionnaires. Attend 3 supervised sessions per week for 6 weeks. Each session lasts ~70 min:

5 min warm-up on cycle ergometer 5 min core-stability work 50 min strength circuit (6 exercises, 2 min between sets, 3 min between exercises) 10 min stretching/cool-down One-repetition maximum (1RM) re-tested at week 3 to adjust load. Final assessment within 3 days after the last training session (same tests as baseline).

Detailed Description

Detailed Description This single-center, prospective, randomized controlled trial will enroll 48 patients who have undergone primary anterior cruciate ligament reconstruction (ACLR) at Chongli Campus, Peking University Third Hospital. After providing written informed consent, participants will be randomly allocated in a 1:1 ratio to either the unilateral resistance training (URT) group or the bilateral resistance training (BRT) group (24 per group).

URT: Each exercise is performed independently with one limb at a time, isolating the target limb while contralateral stabilizers are simultaneously activated to maintain balance.

BRT: Both limbs simultaneously move against a shared resistance, keeping the center of gravity stable and the movement symmetrical.

Baseline assessments will be completed within one week before the first training session; post-intervention testing will occur within three days after the final session. The program lasts six weeks, with three supervised sessions per week. Every session comprises:

5-min warm-up on a cycle ergometer 5-min core-stability work 50-min strength training (the only component that differs between groups) 10-min stretching and cool-down Six exercises are prescribed in identical order for both groups: towel-squeeze press, seated leg press, knee-extension against resistance, long-lever glute bridge, prone hamstring curl, and Romanian dead-lift. Two minutes of rest are given between sets; three minutes separate exercises. Load is set at 60 % of the relevant one-repetition maximum (1RM), re-tested at baseline and week 3 to allow progression.

URT protocol: Each exercise is executed first by the involved leg, then immediately by the uninvolved leg; completion of both sides constitutes one set. The time needed for the uninvolved leg is counted as part of the inter-set interval.

BRT protocol: Both legs work simultaneously; 1RM is determined bilaterally. Training volume, frequency, session duration, and progression criteria are therefore identical; only the resistance modality (unilateral vs bilateral) differs.

Primary outcomes are limb-symmetry indices for peak torque of knee extensors and flexors (isokinetic dynamometry). Secondary endpoints include feed-forward motor control scores, Lysholm knee scale, and IKDC 2000 subjective evaluation. All measurements are obtained pre-intervention and at week 6. The study will determine whether six weeks of URT confers superior strength recovery and inter-limb symmetry compared with conventional BRT after ACLR.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 30-55 years
  • ACLR performed with hamstring-tendon autograft ≥ 3 months ago
  • Full extension (no loss) and ≤ 5° difference in knee-flexion range between limbs, with flexion ≥ 120°
  • Able to recruit quadriceps adequately (no lag during 10 consecutive straight-leg raises on the involved side)
  • Can stand pain-free on the involved leg for ≥ 5 s without support
  • Has signed informed consent and can complete all study procedures

Exclusion Criteria

  • Previous lower-limb surgery on either leg, including revision ACLR
  • Any prior knee surgery on the contralateral limb
  • Associated ligament ruptures or fractures
  • Severe patellar chondral damage
  • Post-operative arthrofibrosis
  • Professional athletes
  • Cardiac disease
  • Pregnant or lactating women

Outcomes

Primary Outcomes

muscle strength

Time Frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)

Isokinetic muscle strength test Before the test, the participants were instructed on the basic principles of isokinetic strength testing and were required to perform three maximum knee extensions as a warm-up. After the warm-up, the patients rested for 2 minutes, and then performed 5 repetitions at speeds of 60°/s and 180°/s. The peak torque values (PT) of the quadriceps and hamstring muscles of both limbs during the 5 attempts were recorded.

Secondary Outcomes

  • Thigh circumference measurement (unit: cm)(Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study))
  • Lysholm knee score scale(Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study))
  • Knee joint IKDC 2000 score(Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study))
  • Single-leg jump (unit: cm)(Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study))
  • Landing Error Scoring System,LESS(Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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