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Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803566
Recruitment Status : Suspended (The grant application has not been approved)
First Posted : January 14, 2019
Last Update Posted : April 13, 2020
Sponsor:
Information provided by (Responsible Party):
Roger Enoka, University of Colorado, Boulder

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aging Other: Pegboard practice Other: Force control practice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : July 2026

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.
Other: Pegboard practice
Practice of the grooved pegboard test

Other: Force control practice
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.
Other: Pegboard practice
Practice of the grooved pegboard test

Other: Force control practice
Practice performing steady muscle contractions




Primary Outcome Measures :
  1. Grooved pegboard test [ Time Frame: Changes from baseline (week 1) at weeks 4 and 7 ]
    Time to complete the test as quickly as possible

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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

  2. MVC force [ Time Frame: Changes from baseline (week 1) at weeks 4 and 7 ]
    The peak force exerted during a maximal isometric contractions

  3. 1-RM load [ Time Frame: Changes from baseline (week 1) at weeks 4 and 7 ]
    The maximal weight that can be lifted once

  4. 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

  5. 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



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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803566


Locations
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United States, Colorado
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
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Principal Investigator: Roger Enoka, PhD University of Colorado, Boulder
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Responsible Party: Roger Enoka, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03803566    
Other Study ID Numbers: 18-0269
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger Enoka, University of Colorado, Boulder:
Manual dexterity