N/A
N=42
Combined Application of Electrical Stimulation and Volitional Contractions for Muscle Strengthening and Knee Pain Inhibition (Seated Study)
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02802878 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer. — 0.06; 0.03 Newton-meters/kilogram — p=.67
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hybrid Training using Electrodes and Joint Motion Sensors (Device); Isokinetic Training with Isokinetic Dynamometer (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer. |
0.06; 0.03 | .67 |
| SECONDARY Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer. |
0.05; 0.06 | — |
| SECONDARY Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score |
11.9; 14.1 | — |
| SECONDARY Change in 20-meter Walk Time |
-1.60; -0.95 | — |
| SECONDARY Change in 5-chair Stand Time |
-4.81; -1.86 | — |
Summary
The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular electrical stimulation with volitional contraction (NMES-VC) training program to improve quadriceps strength and activation, while not adversely affecting knee-related pain, activities of daily living or quality of life in women with knee pain. The primary outcome will be change in maximal isokinetic knee extensor torque.
The investigators will test the following hypotheses. In comparison with low-load (40%) resistance training without electrical stimulation, a 12-week NMES-VC training program will:
Hypothesis 1: Increase maximal isokinetic knee extensor torque
Secondary questions and response variables
Hypothesis 2: Not adversely affect knee pain or quality of life, assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA:
1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development
2. Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated (using numeric rating scale survey "level of pain you experienced during the hybrid training or 40% isokinetic exercise")
3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)
Eligibility Criteria
Inclusion Criteria
- Female
- Age 40-85 years
- One or more of the following:
- Knee symptoms (pain, aching, or stiffness) on most of the last 30 days; categorically defined, so all severity of symptoms ok, but must have knee symptoms on most days
- History of knee injury or surgery
- Body Mass Index (BMI) greater than or equal to 25 kg/m2
- BMI less than 45 kg/m2
Exclusion Criteria
- Knee injection within 6 weeks prior to the study
- Resistance training at any time in the last 3 months prior to the study
- Bilateral knee replacement
- Lower limb amputation
- Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
- Back, hip or knee problems that affect walking ability or ability to exercise
- Unable to walk without a cane or walker
- Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
- Multiple sclerosis or other neurodegenerative disorder
- Known neuropathy
- Self-report of Diabetes
- Currently being treated for cancer or having untreated cancer
- Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
- Peripheral Vascular Disease
- History of myocardial infarction or stroke in the last year
- Chest pain during exercise or at rest
- Use of supplemental oxygen
- Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
- Staff concern for participant health (such as history of dizziness/faintness or current restrictions on activity)
- Unable to attend 12 or more sessions during the study
- Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or other implanted electrical device.
- Dermatitis or skin sensitivity.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02802878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.