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Completed

NCT Number: NCT01708980

Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement

Background:

In the early phase after a total knee replacement (TKA), patients experience multi-level weakness in the operated leg, which is caused primarily by reduced central (CNS) activation failure of the muscles - especially the knee extensors. This considerable loss of muscle strength relates to reduced functional performance. The investigators recently reported that early-commenced physiotherapy, including progressive strength training performed in machines, seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the operated leg, elicited during strength training in machines, can be reached during strength training in more simple forms? Many clinicians are faced with the problem of not having strength training equipment at their institution, or having to prescribe simple strength training exercises for home-based training.

Purpose and hypothesis:

The purpose of this study is to determine which strength training exercises that activate the muscles in the operated leg the most after TKA. The hypothesis is that strength training exercises performed in machines is more effective compared to strength training performed in more simple forms (using elastic bands or own body weight, etc.).

Participants and methods:

Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first investigation, will be included. The participants are investigated twice. During the first investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a load that can be lifted exactly 10 times) will be determined for all the exercises. At least 72 hours later, the participants will undergo an electromyographic analysis, which determines the neuromuscular activity of the thigh muscles in the operated leg.

Ethical issues:

From a pilot study, the investigators found that strength training exercises commenced early after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain. None of the financial supporters, or any of the authors, have any potential conflicts of interest with regard to the study.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Centre, Copenhagen University Hospital, Hvidovre

Hvidovre, Copenhagen, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral primary TKA
  • Between the age of 18 to 80 years
  • Understand and speak Danish
  • Informed consent
  • 4 to 8 weeks after TKA

Exclusion criteria

  • Disease/Musculoskeletal disorder, which requires a special rehabilitation modality
  • Alcohol and drug abuse
  • Lack of wish to participate or unwillingness to sign an informed consent

Treatment and study plan

Six different strength training exercises

Other

Electromyographic (EMG) activity of the vastus medialis, vastus lateralis, semitendinosus and biceps femoris muscles of the operated leg will be recorded during 6 different strength training exercises. The six exercises performed unilaterally are: seated knee extensions and leg presses in machines (gold standard exercises), and the four other exercises are: sit-to-stands, squats, straight leg raises and seated knee extensions using an elastic band.

The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM of the 6 strength training exercises is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.

Other names: Resistance training

Primary outcomes

  1. Normalized neuromuscular activity (EMG) of the quadriceps and hamstring muscles

    Time frame: One time point, 4 to 8 weeks after TKA

    Normalized electromyographic (EMG) activity (amplitude) during the different exercises. The EMG activity elicited during standardized, maximal contractions is used as a reference for normalization.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Registry information

Official study title

Neuromuscular Activity of the Operated Leg During Strength Training Performed in Machines and in More Simple Forms After Total Knee Replacement

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2012
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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