Neuromuscular Electrical Stimulation and Physical Function in Older Adults

NCT03509519 | Unknown

• 1 other identifier: REPFY18
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia

Keywords

neuromuscular electrical stimulation; physical activity; muscular strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in Muscle Strength

  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 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

  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

  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

  BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.

Study Arms (2)

NMES-Millicurrent Group

EXPERIMENTAL

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

NMES-Microcurrent Group

SHAM COMPARATOR

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

Interventions

NMES-Millicurrent OTHER

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.

NMES-Microcurrent Group; NMES-Millicurrent Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• generally healthy men and women
• ages 60 and older

You may not qualify if:

• \) they have participated in regular resistance training exercise or physical rehabilitation of the lower extremity within 2 months of the study
• \) 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)
• \) they have current knee injury or knee pain
• \) have a neuromuscular disease
• \) currently taking insulin for diabetes regulation
• \) they have a history of seizures

Sponsors & Collaborators

• Texas State University: lead

Related Publications (3)

• 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.

  PMID: 20101013 BACKGROUND

• 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.

  PMID: 25104935 BACKGROUND

• 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.

  PMID: 14687319 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Joni A Mettler, PhD

  Texas State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joni A Mettler, PhD

CONTACT

512-245-9691; jam388@txstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This clinical trial will use a pre-test - post-test randomized experimental design. Subject will be randomly assigned to the treatment group or the sham group. Study outcomes will be measured pre- and post-intervention.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 26, 2018
• Study Start: April 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share