Neuromuscular Electrical Stimulation and Physical Function in Older Adults

Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults

The purpose of this placebo controlled clinical trial is to examine the effects of of neuromuscular electrical stimulation (NMES) training on physical activity, muscle function, self-efficacy, and blood markers [e.g., brain-derived neurotrophic factor (BDNF)] in older adults.

It is hypothesized that 4-weeks of NMES will increase 1) physical activity, 2) muscle function, 3) self-efficacy, and 4) BDNF in older adults.

Sarcopenia is a destructive progressive cycle of impaired physical function resulting in loss of muscle mass, strength, and self-confidence in ability to perform physical activities, compounded by difficulty walking and ultimately reduced physical activity levels for many older adults. Neuromuscular electrical stimulation (NMES) is a common therapeutic modality used to create involuntary muscle contractions as a means to increase muscle strength, and may be an effective treatment for improving muscle function and physical activity levels in older adults with sarcopenia. Thus, it is critical to explore viable and effective alternative therapies to increase physical activity. The goal of the investigators' is to determine the effectiveness of neuromuscular electrical stimulation (NMES) at increasing physical activity and related biological, psychological, and muscle function factors. This placebo controlled clinical trial will use a pre-test - post-test randomized experimental design.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia
• Intervention / Treatment: Other: NMES-Millicurrent

Detailed Description

Older healthy adults (60 and older) will participate in this study. Participants will undergo 4 weeks of neuromuscular electrical stimulation (NMES) training. Participants will be randomized into the one of two groups 1) NMES-millicurrent or 2) NMES microcurrent. Participants will undergo pre- and post-training testing for muscle function, physical function, and psychological variables related to physical activity. Blood samples will also be obtained pre- and post-training.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joni A Mettler, PhD; Phone Number: 512-245-9691; Email: jam388@txstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• generally healthy men and women
• ages 60 and older

Exclusion Criteria:

• 1) they have participated in regular resistance training exercise or physical rehabilitation of the lower extremity within 2 months of the study
• 2) contraindicating conditions for electrical stimulation are present (i.e., swollen, infected or inflamed areas including open wounds, or painful areas on the lower limbs, implanted electronics including cardiac pacemakers, electronic infusion pumps, implanted stimulators, or surgical hardware in the lower limbs)
• 3) they have current knee injury or knee pain
• 4) have a neuromuscular disease
• 5) currently taking insulin for diabetes regulation
• 6) they have a history of seizures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NMES-Millicurrent Group; NMES-millicurrent group will receive the NMES experimental treatment. Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min on each leg.	Other: NMES-Millicurrent; Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg.
SHAM_COMPARATOR: NMES-Microcurrent Group; The NMES-microcurrent group will receive the Sham Treatment. The Sham Treatment will consist of electrode pad application for 40 mins on each leg, but electrical current will not be delivered. Otherwise all procedures will be the same as the NMES-millicurrent experimental group. Participants will be informed they are receiving microcurrent stimulation which is typically not felt by patients. Microcurrent stimulation is an actual type of electrical stimulation that is used therapeutically and is typically not felt by patients, however, participants will not receive this treatment. Participants will be informed of the actual treatment received at the study conclusion. Those in the Sham Group will be given the opportunity to receive the treatment at the conclusion of the study.	Other: NMES-Millicurrent; Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	Physical activity will be measured from accelerometer data.	Physical activity levels will be assessed for 1 week before the intervention and for 1 week after the intervention period. The change in physical activity will be compared between these two time-periods.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Muscle Strength	Muscle strength will be measured by maximal voluntary contraction on a dynamometer.	Muscle strength will be assessed prior to the first day of the intervention, after 2-weeks of the intervention, and two days after the completion of the 4-week intervention.
Change in Muscle Endurance	Muscle endurance time will be measured on a dynamometer.	Muscle endurance will be assessed prior to the first day of the intervention and 2 days after the completion of the 4-week intervention.
Pre-training NMES-related change in glucose	Fasting blood glucose levels will be measured.	Blood glucose will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Post-training NMES-related change in glucose	Fasting blood glucose levels will be measured.	Blood glucose will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Pre-training NMES-related change in Brain-derived Neurotrophic Factor (BDNF) levels	Brain-derived neurotrophic factor, a marker of neuronal growth, will be obtained from a blood sample.	BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Post-intervention change in Brain-derived Neurotrophic Factor (BDNF) levels	Brain-derived neurotrophic factor, a marker of neuronal growth, will be obtained from a blood sample.	BDNF levels will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Change in self-efficacy of activities of daily living	Self-efficacy will be measured by survey.	Self-efficacy will be measured prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in motor activation	Motor activation will be measured by surface electromyography measures.	Motor activation will be measured prior to the first day of the intervention and two days after the completion of the 4-week intervention.
Change in perception of pain	Perceived pain experienced during the NMES treatment will be measured by survey.	Perceptions of pain will be measured immediately after the NMES treatment on the first (training day 1) and last day (training day 12) of the 4-week intervention.
Physical activity during the 4-week intervention	Physical activity will be measured from accelerometer data.	Physical activity levels will be measured during the 4 weeks of the intervention (from the first day of the intervention through the last day of the intervention).
Change in timed up and go test	The timed up and go test will measure the time it takes to stand up from a chair, walk a few meters, turn around and sit back down.	Timed up and go test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in stair climb test	The stair climb test will assess the time it takes to safely ascend 10 stairs.	The stair cimb test test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in five repetition sit-to-stand test	The five repetition sit-to-stand test will assess the time it take to stand up and sit down on a chair 5 times.	The five repetition sit-to-stand test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in 6-min walk test	The 6-min walk test will assess the distance an individual can walk in 6 minutes.	The 6-min walk test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in grip strength	The grip strength test will measure the maximal hand grip strength of both hand using a grip strength dynamometer.	The grip strength test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in arm curl test	The arm curl test will measure the number of repetitions completed with a dumbbell.	The arm curl test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.

Collaborators and Investigators

• Sponsor: Texas State University
• Investigators: Principal Investigator: Joni A Mettler, PhD, Texas State University

Publications and helpful links

General Publications

• Kemmler W, von Stengel S, Engelke K, Haberle L, Kalender WA. Exercise effects on bone mineral density, falls, coronary risk factors, and health care costs in older women: the randomized controlled senior fitness and prevention (SEFIP) study. Arch Intern Med. 2010 Jan 25;170(2):179-85. doi: 10.1001/archinternmed.2009.499.
• Kern H, Barberi L, Lofler S, Sbardella S, Burggraf S, Fruhmann H, Carraro U, Mosole S, Sarabon N, Vogelauer M, Mayr W, Krenn M, Cvecka J, Romanello V, Pietrangelo L, Protasi F, Sandri M, Zampieri S, Musaro A. Electrical stimulation counteracts muscle decline in seniors. Front Aging Neurosci. 2014 Jul 24;6:189. doi: 10.3389/fnagi.2014.00189. eCollection 2014.
• Janssen I, Shepard DS, Katzmarzyk PT, Roubenoff R. The healthcare costs of sarcopenia in the United States. J Am Geriatr Soc. 2004 Jan;52(1):80-5. doi: 10.1111/j.1532-5415.2004.52014.x.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: physical activity; neuromuscular electrical stimulation; muscular strength
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: REPFY18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share data with other researches until the data are published in journals and presented at conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No