Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population

NCT03409575 | Completed

• 1 other identifier: AR-1665
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief Summary

The decline in physical function and strength was seen by the nature of aging. The older adults often complain of fatigue. For these reasons, proper rehabilitation approaches should be used to ensure healthy life and to keep the quality of life at the highest possible level by minimizing the decline seen with aging process. Exercise programs and Neuromuscular Electrical Stimulation (NMES) are applied in rehabilitation to restore muscular strength and improve physical performance. NMES is used to prevent the atrophy of nonuse, to increase joint range of motion, to re-educate muscle, to regulate spasticity, to replace orthosis, to improve motor involvement of muscle fibers. Despite the use of NMES for strengthening in the clinics, the application parameters and methods should be discussed. The frequency, the pulse duration, the on / off time, the amplitude, the waveform of the current and the application time vary between the studies. For geriatric populations, it is recommended that the highest intensity, biphasic symmetrical currents with a frequency in the range of 50-100 Hz, for 100-400 μs, can be pulsed for ideal amplification. NMES is usually practiced by physiotherapists continuously for 20 minutes in to strengthen. However, in recent studies, it has been shown that continuous application of a single-session 100 Hz current for 20 minutes leads to intense fatigue and after a while the effect of the strengthening of the current has been removed. Therefore, intermittent applications have been proposed instead of continuous applications for 20 minutes. Considering the fragility and the presence of sarcopenia in the geriatric population, NMES applications should be preferred in which rest periods are given instead of continuous application for 20 minutes. In the literature, there is no study showing the effect of NMES on Quadriceps strength, fatigue and physical function by using quadriceps stimulation for 20 minutes using different stimulation periods.Therefore, in this study, will be investigated the possible effects of two different methods of NMES on Quadriceps strength, fatigue and physical function.

Conditions

Age-Related Atrophy; Physical Disorder

Keywords

neuromuscular electrical stimulation; geriatric population; physical function; quadriceps; fatigue

Outcome Measures

Primary Outcomes (3)

• Timed up and go test

  This test will be used to measure the progress of balance, sit to stand, and walking. The participants stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Time will be recorded.

  2 minutes

• 30-Second Chair Stand Test

  The 30CST is a measurement that assesses functional lower extremity strength in older adults. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Incorrectly executed stands are not counted.

  30 second

• 6 minute walk test

  The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The participant walk for 6 minutes on 30 meter long way. The total distance will be recorded at the end of the test.

  6 minute

Secondary Outcomes (5)

• Grip Strength

  5 minutes

• Berg Balance Scale

  10 minutes

• Strength of Quadriceps muscle

  5 minutes.

• Short Physical Performance Battery

  3 minutes

• Fatigue Severity Scale

  5 minutes

Study Arms (2)

5 minutes stimulation

OTHER

The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 5 minutes.

Other: 5 minutes stimulation

10 minutes stimulation

OTHER

The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 10 minutes.

Other: 10 minutes stimulation

Interventions

5 minutes stimulation OTHER

Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes. NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.). Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions). Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 5 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes. 5 minutes of NMES will be made in 4 sets. Fifteen contractions will be received at each set. The intensity of the current will be increased until the visible contraction is taken.

5 minutes stimulation

10 minutes stimulation OTHER

Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes. NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.). Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions). Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 10 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes. 10 minutes of NMES will be made in 2 sets. Thirty contractions will be received at each set. The intensity of the current will be increased until the visible contraction is taken.

10 minutes stimulation

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• age 60 years or older
• be able to climb one floor of stairs independently
• not participate in an exercise program to increase strength or physiotherapy programme.

You may not qualify if:

• having a medical condition in which NMES training is contraindicated
• having a cognitive impairment
• having implanted cardiac pacemaker

Sponsors & Collaborators

• Sevim ACARÖZ CANDAN: lead
• Scientific Researches Project Coordination Department of Ordu University: collaborator

Study Sites (2)

Sevim ACARÖZ CANDAN

Ordu, Altinordu, 52100, Turkey (Türkiye)

Location

Sevim ACARÖZ CANDAN

Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sevim A CANDAN

  Ordu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: February 5, 2018
• Primary Completion: March 16, 2018
• Study Completion: March 21, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)