SarcopeniaNCT03509519
Neuromuscular Electrical Stimulation and Physical Function in Older Adults
A study testing NMES-Millicurrent in people with Sarcopenia, run by Texas State University.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- NMES-Millicurrent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy men and women
- ages 60 and older
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- NMES-Millicurrent
- Keywords
- neuromuscular electrical stimulation, physical activity, muscular strength
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES-MillicurrentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NMES-Millicurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity
Physical activity will be measured from accelerometer data.
Measured: 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 measured by maximal voluntary contraction on a dynamometer.
Measured: 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.
Measured: 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.
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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joni Mettler, Texas State University
- Investigators
- Joni A Mettler, PhD, Principal investigator, Texas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509519
- Sponsor's protocol ID
- REPFY18
- Status last verified
- Apr 2018
- First submitted
- 7 Mar 2018
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share data with other researches until the data are published in journals and presented at conferences.
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.
PubMed 20101013Kern 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.
PubMed 25104935Janssen 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.
PubMed 14687319
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT03509519
- Acronym / sponsor ID
- REPFY18
- Conditions
- Sarcopenia
- Keywords
- neuromuscular electrical stimulation, physical activity, muscular strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Texas State UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NMES-Millicurrent Group | Experimental | Other: NMES-MillicurrentNMES-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. |
| NMES-Microcurrent Group | Sham comparator | Other: NMES-MillicurrentThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- generally healthy men and women
- ages 60 and older
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES-MillicurrentStimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg. | Other | NMES-Microcurrent Group, NMES-Millicurrent Group |
Primary outcome
Change in Physical Activity
Time frame: 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.
Physical activity will be measured from accelerometer data.
16 secondary outcomes
Change in Muscle Strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 20101013Kemmler 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.
- Background: PubMed 25104935Kern 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.
- Background: PubMed 14687319Janssen 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.
- Individual participant dataSharing planned: No. We do not plan to share data with other researches until the data are published in journals and presented at conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joni A Mettler, PhD principal investigator
Texas State University
Questions about this trial
What is this clinical trial studying?
A study testing NMES-Millicurrent in people with Sarcopenia, run by Texas State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joni A Mettler, PhD (512-245-9691, jam388@txstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509519, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.