Neuromuscular Electrical Stimulation and Physical Function in Older Adults

Sarcopenia Clinical Trial

Official title:

Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03509519
• Other study ID #: REPFY18
• Status: Not yet recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: April 16, 2018
• Start date: April 2018
• Est. completion date: March 2020

Study information

• Verified date: April 2018
• Source: Texas State University
• Contact: Joni A Mettler, PhD
• Phone: 512-245-9691
• Email: jam388[@]txstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas State University

References & Publications (3)

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. — View Citation

Kemmler W, von Stengel S, Engelke K, Häberle 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. — View Citation

Kern H, Barberi L, Löfler 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.