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Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population

Primary Purpose

Age-Related Atrophy, Physical Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
5 minutes stimulation
10 minutes stimulation
Sponsored by
Sevim ACARÖZ CANDAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Age-Related Atrophy focused on measuring neuromuscular electrical stimulation, geriatric population, physical function, quadriceps, fatigue

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria includes

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Sevim ACARÖZ CANDAN
  • Sevim ACARÖZ CANDAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

5 minutes stimulation

10 minutes stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Grip Strength
The patient wiil squeeze the dynamometer as the arm is adjacent to the body, the elbow is at 90 ° flexion, the forearm is in the neutral position and the wrist is at 0-30 ° extension. After the test is repeated three times, the highest score will be recorded. The test will only be done for the dominant hand.
Berg Balance Scale
The balance will be evaluated observational during 14 different balance activities. A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. It's minimum and maximum scores ranged between 0 and 56. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk
Strength of Quadriceps muscle
Lafayette manuel muscle tester will be used to determine the strength of the Quadriceps. The strength will be evaluated bilaterally three times and then the maximum value will be recorded.
Short Physical Performance Battery
The battery is an objective assessment tool for evaluating lower extremity functioning in older persons. The battery is scored between 0-12 scores according to the balance, chair stand test performance and gait speed of the participant.
Fatigue Severity Scale
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Each item is scored between1 and 7. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. A total score of 36 or more suggests that you may be suffering from the fatigue.

Full Information

First Posted
January 17, 2018
Last Updated
March 21, 2018
Sponsor
Sevim ACARÖZ CANDAN
Collaborators
Scientific Researches Project Coordination Department of Ordu University
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1. Study Identification

Unique Protocol Identification Number
NCT03409575
Brief Title
Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population
Official Title
Efficacy of Two Different Method of Neuromuscular Electrical Stimulation on Quadriceps Strength, Fatigue and Physical Function in Geriatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sevim ACARÖZ CANDAN
Collaborators
Scientific Researches Project Coordination Department of Ordu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Atrophy, Physical Disorder
Keywords
neuromuscular electrical stimulation, geriatric population, physical function, quadriceps, fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 minutes stimulation
Arm Type
Other
Arm Description
The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 5 minutes.
Arm Title
10 minutes stimulation
Arm Type
Other
Arm Description
The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 10 minutes.
Intervention Type
Other
Intervention Name(s)
5 minutes stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
10 minutes stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timed up and go test
Description
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.
Time Frame
2 minutes
Title
30-Second Chair Stand Test
Description
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.
Time Frame
30 second
Title
6 minute walk test
Description
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.
Time Frame
6 minute
Secondary Outcome Measure Information:
Title
Grip Strength
Description
The patient wiil squeeze the dynamometer as the arm is adjacent to the body, the elbow is at 90 ° flexion, the forearm is in the neutral position and the wrist is at 0-30 ° extension. After the test is repeated three times, the highest score will be recorded. The test will only be done for the dominant hand.
Time Frame
5 minutes
Title
Berg Balance Scale
Description
The balance will be evaluated observational during 14 different balance activities. A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. It's minimum and maximum scores ranged between 0 and 56. Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk
Time Frame
10 minutes
Title
Strength of Quadriceps muscle
Description
Lafayette manuel muscle tester will be used to determine the strength of the Quadriceps. The strength will be evaluated bilaterally three times and then the maximum value will be recorded.
Time Frame
5 minutes.
Title
Short Physical Performance Battery
Description
The battery is an objective assessment tool for evaluating lower extremity functioning in older persons. The battery is scored between 0-12 scores according to the balance, chair stand test performance and gait speed of the participant.
Time Frame
3 minutes
Title
Fatigue Severity Scale
Description
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Each item is scored between1 and 7. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. A total score of 36 or more suggests that you may be suffering from the fatigue.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria includes 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. Exclusion Criteria: having a medical condition in which NMES training is contraindicated having a cognitive impairment having implanted cardiac pacemaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevim A CANDAN
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sevim ACARÖZ CANDAN
City
Ordu
State/Province
Altinordu
ZIP/Postal Code
52100
Country
Turkey
Facility Name
Sevim ACARÖZ CANDAN
City
Ordu
ZIP/Postal Code
52100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Neuromuscular Electrical Stimulation in Geriatric Population

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