Anterior Cruciate Ligament Reconstruction RehabilitationNCT07271173
Study on the Effects of Unilateral Resistance Training on Lower Limb Muscle Strength and Symmetry After Anterior Cruciate Ligament Reconstruction Surgery
A study testing resistance training in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Peking University Third Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital of Chongli
Zhangjiakou, Hebei, 076350
About this study
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:
Read more
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).
Read the 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.
- Being tested
- resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingBehavioural
After signing the informed consent form, the relevant indicators for the pre-trial tests can be conducted.Outcome assessments are conducted at baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study).The entire trial period lasts for 6 weeks, with 3 training sessions per week. The entire training process includes 5 minutes of warm-up (power bike), 5 minutes of core strength training, 50 minutes of muscle strength training, and 10 minutes of stretching training. The training methods of the two groups are only different in the muscle strength training method. The experimental group (URT group) performs unilateral resistance training for both lower limbs, while the control group (BRT group) performs bilateral resistance training for both lower limbs. There are a total of 6 training actions: towel roll compression training, sitting leg-cranking training, knee extension resistance training, distant hip bridge train
| Study group | Role | What they receive |
|---|---|---|
| Control group: Bilateral resistance training group | Active comparator | Control group: Bilateral resistance training (BRT, referring to the training method where both limbs (both hands or both legs) simultaneously resist the same resistance. The force is transmitted synchronously on both sides, the center of gravity is stable, and the movements are symmetrical). The movements in the BRT group were similar to those in the URT group. Each movement was completed simultaneously by both legs. The resistance setting was based on measuring the 1RM of both lower limbs (60% of 1RM). Receives: Behavioral: resistance training |
| Experimental group: Unilateral resistance training group | Experimental | Experimental group: Unilateral Resistance Training (URT, referring to the training method where one limb (either one hand or one leg) performs resistance movements independently, emphasizing the application of load to the target limb while activating the stabilizing muscle groups on the opposite side to maintain balance). In the URT group, each movement is performed first by the affected leg and then by the healthy leg. A set is completed when both legs have finished. After the training of the affected leg, the timing begins. The training time of the healthy leg also counts as the interval time. The resistance setting is measured separately for each side of the lower body's single side (1RM) at 60% of 1RM. Receives: Behavioral: resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
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.
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Secondary outcomes (5)
Thigh circumference measurement (unit: cm)
The patient lies on their back, in a relaxed position, with both legs naturally apart. The tape measure is placed 10 cm above the upper edge of the patella and measures the length for one week. (During the measurement, the tape measure should be firmly attached to the skin, not too tight or too loose.) Measurements are taken three times on each side, and the average value is calculated, accurate to one decimal place.
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Lysholm knee score scale
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Knee joint IKDC 2000 score
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Single-leg jump (unit: cm)
Single-leg jump (unit: cm):
The patient places both hands behind their back and performs a single-leg jump. Measure three times and take the farthest distance. The patient is instructed to start from the uninjured leg and place their toes behind the marked starting line. Use a standard tape measure to measure the jumping distance from the starting line to the patient's heel. The measurement can be taken only if the patient can remain stable after landing; otherwise, the measurement needs to be redone.
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Landing Error Scoring System,LESS
Measured: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start6 Apr 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271173
- Sponsor's protocol ID
- M2025001
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Unilateral Resistance Training on Lower Limb Muscle Strength and Symmetry After Anterior Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT07271173
- Acronym / sponsor ID
- M2025001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: Bilateral resistance training group | Active comparator | Behavioral: resistance trainingControl group: Bilateral resistance training (BRT, referring to the training method where both limbs (both hands or both legs) simultaneously resist the same resistance. The force is transmitted synchronously on both sides, the center of gravity is stable, and the movements are symmetrical). The movements in the BRT group were similar to those in the URT group. Each movement was completed simultaneously by both legs. The resistance setting was based on measuring the 1RM of both lower limbs (60% of 1RM). |
| Experimental group: Unilateral resistance training group | Experimental | Behavioral: resistance trainingExperimental group: Unilateral Resistance Training (URT, referring to the training method where one limb (either one hand or one leg) performs resistance movements independently, emphasizing the application of load to the target limb while activating the stabilizing muscle groups on the opposite side to maintain balance). In the URT group, each movement is performed first by the affected leg and then by the healthy leg. A set is completed when both legs have finished. After the training of the affected leg, the timing begins. The training time of the healthy leg also counts as the interval time. The resistance setting is measured separately for each side of the lower body's single side (1RM) at 60% of 1RM. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resistance trainingAfter signing the informed consent form, the relevant indicators for the pre-trial tests can be conducted.Outcome assessments are conducted at baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study).The entire trial period lasts for 6 weeks, with 3 training sessions per week. The entire training process includes 5 minutes of warm-up (power bike), 5 minutes of core strength training, 50 minutes of muscle strength training, and 10 minutes of stretching training. The training methods of the two groups are only different in the muscle strength training method. The experimental group (URT group) performs unilateral resistance training for both lower limbs, while the control group (BRT group) performs bilateral resistance training for both lower limbs. There are a total of 6 training actions: towel roll compression training, sitting leg-cranking training, knee extension resistance training, distant hip bridge train | Behavioural | Control group: Bilateral resistance training group, Experimental group: Unilateral resistance training group |
Primary outcome
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.
5 secondary outcomes
Thigh circumference measurement (unit: cm)
Time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Lysholm knee score scale
Time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Knee joint IKDC 2000 score
Time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Single-leg jump (unit: cm)
Time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Landing Error Scoring System,LESS
Time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: Baseline (1 day before the intervention) and 3 days after the final training session (day 45 of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.