Clinical trial NCT03509519: Neuromuscular Electrical Stimulation and Physical Function in Older Adults
Official title: Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: neuromuscular electrical stimulation
physical activity
muscular strength
Lead sponsor: Texas State University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity
timeFrame: 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:
measure: Change in Muscle Strength
timeFrame: 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.
measure: Change in Muscle Endurance
timeFrame: Muscle endurance will be assessed prior to the first day of the intervention and 2 days after the completion of the 4-week intervention.
measure: Pre-training NMES-related change in glucose
timeFrame: Blood glucose will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
measure: Post-training NMES-related change in glucose
timeFrame: 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.
measure: Pre-training NMES-related change in Brain-derived Neurotrophic Factor (BDNF) levels
timeFrame: BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
measure: Post-intervention change in Brain-derived Neurotrophic Factor (BDNF) levels
timeFrame: 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.
measure: Change in self-efficacy of activities of daily living
timeFrame: 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.
measure: Change in motor activation
timeFrame: Motor activation will be measured prior to the first day of the intervention and two days after the completion of the 4-week intervention.
measure: Change in perception of pain
timeFrame: 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.
measure: Physical activity during the 4-week intervention
timeFrame: 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).
measure: Change in timed up and go test
timeFrame: 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.
measure: Change in stair climb test
timeFrame: 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.
measure: Change in five repetition sit-to-stand test
timeFrame: 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.
measure: Change in 6-min walk test
timeFrame: 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.
measure: Change in grip strength
timeFrame: 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.
measure: Change in arm curl test
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Texas State University
name: Joni A Mettler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.