Nerve DegenerationNCT06614556
Quantifying the Trainability of Peripheral Nerve Function in Young and Older Adults.
A study testing Resistance Training in people with Nerve Degeneration and Healthy Aging, run by Oklahoma State University at 1 site in United States.
Trial summary
The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Degeneration, Healthy Aging
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 18 Jul 2023
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy adults 18 - 100 years old.
Who cannot join
- If you have been notified by a physician to refrain from exercise due to cardiovascular issues.
- Known orthopedic or neuromuscular limitations or illness of the upper extremities.
- Known neuromuscular disorders.
- Individuals that are experiencing a fever (> 100.4° F) or have identified as symptomatic on the COVID-19 screening questionnaire may not participate at this time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Neuromuscular Physiology Laboratory
Stillwater, Oklahoma, 74078
About this study
The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week resistance training intervention with nerve conduction velocity measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention.
Read the detailed description
Studies have shown that nerve speed slows with advancing age. As a result, slower nerves may result in slower movement speed and can alter response time. The investigators propose that a resistance training intervention may elicit positive adaptations to the nerves. The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week, at-home, resistance training intervention with nerve conduction velocity (m/s) measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention. Other outcome measures included nerve size, via ultrasound, maximal handgrip strength, and hand dexterity.
- Conditions
- Nerve Degeneration, Healthy Aging
- Being tested
- Resistance Training
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Also called Strength Training, Exercise
Participants in the training groups performed bilateral hand grip resistance training three times per week for four weeks using a specialized hand-grip kit provided to them. Participants were provided with pictures and instructions for each exercise upon completion of the initial testing (PRE) session. They were asked to perform 12 training sessions (approximately 30-45 mins) over the 4 weeks according to their schedule. Each participant was asked to keep a training log to assist with accountability. Those assigned to the control groups were asked to maintain their normal daily activities throughout the four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Young Training Group | Experimental | Ages 18-35. Performed 4 weeks of an at-home, hand grip resistance training intervention. Receives: Other: Resistance Training |
| Young Control Group | No intervention | Ages 18-35. Did not perform the training intervention |
| Older Training Group | Experimental | Ages 60+. Performed 4 weeks of an at-home, hand grip resistance training intervention. Receives: Other: Resistance Training |
| Older Control Group | No intervention | Ages 60+. Did not perform the training intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor nerve conduction velocity (m/s)
Conduction velocity of the median nerve, via nerve stimulation, as measured through EMG at the Flexor Digitorum Superficialis muscle
Measured: Before and after 4 weeks of training (or just 4 weeks, for controls)
Secondary outcomes (3)
Nerve cross-sectional area (mm^2)
The area within the visible borders of the nerve, as seen and measured via ultrasound
Measured: Before and after 4 weeks of training (or just 4 weeks, for controls)
Maximal strength (kg)
Maximal handgrip strength using a handgrip dynamometer
Measured: Before and after 4 weeks of training (or just 4 weeks, for controls)
Hand motor dexterity (seconds)
A timed Minnesota manual dexterity task
Measured: Before and after 4 weeks of training (or just 4 weeks, for controls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start20 Sep 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve DegenerationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine - Central States Chapter
- Responsible party
- Sponsor
- Investigators
- Jason M DeFreitas, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614556
- Sponsor's protocol ID
- IRB-22-270
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying the Trainability of Peripheral Nerve Function in Young and Older Adults.
- ClinicalTrials.gov ID
- NCT06614556
- Acronym / sponsor ID
- IRB-22-270
- Conditions
- Nerve Degeneration, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Collaborators
- American College of Sports Medicine - Central States Chapter
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 26 Sep 2024 (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 project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week resistance training intervention with nerve conduction velocity measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention.
Detailed description
Studies have shown that nerve speed slows with advancing age. As a result, slower nerves may result in slower movement speed and can alter response time. The investigators propose that a resistance training intervention may elicit positive adaptations to the nerves. The purpose of this project is to identify the effects of hand grip resistance training on nerve speed of the hand muscles and to quantify whether age plays a role in those effects. Two groups (young and older adults) underwent a 4-week, at-home, resistance training intervention with nerve conduction velocity (m/s) measured before and after. There were also two control groups (young and older adults) who performed the testing 4 weeks apart, but did not engage in the intervention. Other outcome measures included nerve size, via ultrasound, maximal handgrip strength, and hand dexterity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Training Group | Experimental | Other: Resistance TrainingAges 18-35. Performed 4 weeks of an at-home, hand grip resistance training intervention. |
| Young Control Group | No intervention | –Ages 18-35. Did not perform the training intervention |
| Older Training Group | Experimental | Other: Resistance TrainingAges 60+. Performed 4 weeks of an at-home, hand grip resistance training intervention. |
| Older Control Group | No intervention | –Ages 60+. Did not perform the training intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apparently healthy adults 18 - 100 years old.
Key exclusion criteria (4 listed)
- If you have been notified by a physician to refrain from exercise due to cardiovascular issues.
- Known orthopedic or neuromuscular limitations or illness of the upper extremities.
- Known neuromuscular disorders.
- Individuals that are experiencing a fever (> 100.4° F) or have identified as symptomatic on the COVID-19 screening questionnaire may not participate at this time.
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 |
|---|---|---|
| Resistance TrainingAlso: Strength Training, ExerciseParticipants in the training groups performed bilateral hand grip resistance training three times per week for four weeks using a specialized hand-grip kit provided to them. Participants were provided with pictures and instructions for each exercise upon completion of the initial testing (PRE) session. They were asked to perform 12 training sessions (approximately 30-45 mins) over the 4 weeks according to their schedule. Each participant was asked to keep a training log to assist with accountability. Those assigned to the control groups were asked to maintain their normal daily activities throughout the four weeks. | Other | Older Training Group, Young Training Group |
Primary outcome
Motor nerve conduction velocity (m/s)
Time frame: Before and after 4 weeks of training (or just 4 weeks, for controls)
Conduction velocity of the median nerve, via nerve stimulation, as measured through EMG at the Flexor Digitorum Superficialis muscle
3 secondary outcomes
Nerve cross-sectional area (mm^2)
Time frame: Before and after 4 weeks of training (or just 4 weeks, for controls)
Maximal strength (kg)
Time frame: Before and after 4 weeks of training (or just 4 weeks, for controls)
Hand motor dexterity (seconds)
Time frame: Before and after 4 weeks of training (or just 4 weeks, for controls)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Jason M DeFreitas, PhD principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Nerve Degeneration and Healthy Aging, run by Oklahoma State University at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor nerve conduction velocity (m/s) (time frame: Before and after 4 weeks of training (or just 4 weeks, for controls)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2024.