The Efficacy of Rehabilitation Exercise on the Non-operative Limb Following Anterior Cruciate Ligament Reconstruction

NCT02722876 | Completed DMC

• 1 other identifier: EFCOR001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of a cross-education rehabilitation intervention following anterior cruciate ligament reconstruction on ameliorating the acute losses to function and performance. The cross-education phenomenon describes the strength gain in the opposite, untrained (surgical) limb following unilateral resistance training of the 'trained' (non-surgical) limb.

Conditions

Musculoskeletal System

Keywords

Rehabilitation; Cross-education

Outcome Measures

Primary Outcomes (1)

• Muscle Strength (peak force)

  10-weeks post ACL-reconstruction

Secondary Outcomes (5)

• Muscle Strength (peak force)

  6-months post ACL-reconstruction

• Functional capability

  6-months post ACL-reconstruction

• Limb symmetry index

  10-weeks and 6-months post ACL-reconstruction

• Patient perceived knee function

  10-weeks and 6-months post ACL-reconstruction

• Physical activity (PA)

  10-weeks and 6-months post ACL-reconstruction

Study Arms (2)

Contralateral rehabilitation

EXPERIMENTAL

8-weeks of resistance training of the non-operative limb following ACL reconstruction

Other: Contralateral Rehabilitation

Placebo flexibility exercise

PLACEBO COMPARATOR

8-weeks of 'placebo' flexibility training of the upper limb

Other: Placebo flexibility exercise

Interventions

Contralateral Rehabilitation OTHER

Patients will undergo resistance training of the thigh musculature of the non-injured (contralateral) limb 3 times per week. The exercises will consist of unilateral: knee extensions; knee flexions and; leg-press, all performed on commercially-available resistance training machines. To optimise strength gains, patients will work to the 5 repetition-maximum rule (Kraemer et al. 2002); 3 sets of each exercise will be performed and a 2-minute rest will separate each set. Sessions will take no longer than 15-20 minutes, including rest.

Contralateral rehabilitation

Placebo flexibility exercise OTHER

Patients will perform 'placebo' flexibility training of the upper limb, which will involve a time-matched stretching programme targeting the latissimus dorsi, triceps brachii, biceps brachii, trapezius and pectoral muscles of both limbs. Each stretch will be performed twice, held for 20-30 seconds each time and will be followed by a 30-second rest (McCrary et al. 2015)

Placebo flexibility exercise

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mentally mature
• Listed for unilateral ACL reconstructive surgery following informed surgical consent
• Autologous graft tissue; either patella tendon or semitendinosus and gracilis from the ipsilateral leg

You may not qualify if:

• Patients under 16 or over 50 years of age
• Patients with systemic pathologies (e.g. renal failure)
• Symptomatic non-operative knee
• Additional ligament injuries, meniscal transplant and,or, articular cartilage repair to the operative knee

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Related Publications (1)

• Minshull C, Gallacher P, Roberts S, Barnett A, Kuiper JH, Bailey A. Contralateral strength training attenuates muscle performance loss following anterior cruciate ligament (ACL) reconstruction: a randomised-controlled trial. Eur J Appl Physiol. 2021 Dec;121(12):3551-3559. doi: 10.1007/s00421-021-04812-3. Epub 2021 Sep 20.

  PMID: 34542671 DERIVED

Study Officials

• Andrea Bailey, PhD

  The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 30, 2016
• Study Start: January 30, 2017
• Primary Completion: January 6, 2019
• Study Completion: July 8, 2019
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)