- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03803566
Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults
November 12, 2021 updated by: Roger Enoka, University of Colorado, Boulder
The objective of the clinical trial is to evaluate the mediating influence of force control on the pegboard times of adults (50-89 years) who are stratified into groups of faster and slower pegboard times.
The hypothesis is that practice of either a pegboard test or a force-control task will reduce pegboard times, but the decrease will be greater and less similar after the two practice interventions for the slower group of participants.
The outcomes are expected to demonstrate that force control is a modifiable mediator of pegboard times for this cohort, but the effect will be stronger for the group with faster pegboard times.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The study will involve a randomized, cross-over design with a one-week washout between arms.
The two arms (3 weeks each) will comprise practice of the grooved pegboard test and practice of steady contractions while lifting and lowering light loads with a hand muscle.
Randomization into practice order will be accomplished with a block approach (block size = 4) for each of the two groups.
The outcome assessors will be blinded to practice order.
The outcomes will comprise three tests of manual dexterity and the measurement of force control during submaximal contractions.
The outcomes will be obtained before and after the six sessions in each practice arm.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Boulder, Colorado, United States, 80309
- University of Colorado Boulder
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to read, write, and speak English
- Able to arrange transportation to the Boulder campus
Exclusion Criteria:
- Cognitive impairment
- Major psychiatric condition
- Unstable depressive disorder
- Progressive neurological, muscular, cardiovascular, or skeletal disorder
- Chronic pain condition
- Currently taking medication known to influence neuromuscular function
- Recent hospitalization
- Unable to attend 12 practice sessions in 6 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Faster
This group will comprise participants who complete the grooved pegboard test at baseline with a time of less than 71 seconds.
One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
|
Practice of the grooved pegboard test
Practice performing steady muscle contractions
|
Experimental: Slower
This group will comprise participants who complete the grooved pegboard test at baseline with a time of greater than 70 seconds.
One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
|
Practice of the grooved pegboard test
Practice performing steady muscle contractions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grooved pegboard test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
Time to complete the test as quickly as possible
|
Changes from baseline (week 1) at weeks 4 and 7
|
9-hole pegboard test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
Time to complete the test as quickly as possible
|
Changes from baseline (week 1) at weeks 4 and 7
|
Jebsen Hand Function test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
Time to complete the test as quickly as possible
|
Changes from baseline (week 1) at weeks 4 and 7
|
Force control
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
The coefficient of variation for force when subjects exert a constant submaximal force
|
Changes from baseline (week 1) at weeks 4 and 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EMG amplitude
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
Absolute amplitude of the electromyographic (EMG) signal for the involved muscles during the steady contractions
|
Changes from baseline (week 1) at weeks 4 and 7
|
MVC force
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
The peak force exerted during a maximal isometric contractions
|
Changes from baseline (week 1) at weeks 4 and 7
|
1-RM load
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
The maximal weight that can be lifted once
|
Changes from baseline (week 1) at weeks 4 and 7
|
Index finger acceleration
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
The average standard deviation of index finger acceleration in the abduction-adduction plane when a light load is being lifted and lowered during the practice intervention
|
Changes from baseline (week 1) at weeks 4 and 7
|
Motor unit discharge rates
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
|
The discharge times of action potentials by motor units during the steady submaximal contractions
|
Changes from baseline (week 1) at weeks 4 and 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roger Enoka, PhD, University of Colorado, Boulder
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2025
Primary Completion (Anticipated)
November 1, 2025
Study Completion (Anticipated)
July 1, 2026
Study Registration Dates
First Submitted
January 10, 2019
First Submitted That Met QC Criteria
January 10, 2019
First Posted (Actual)
January 14, 2019
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 12, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-0269
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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