The Effect of Upper Limb Low-intensity Motor Control Training Program on Cognitive Function in Healthy Older Adults (uMCON)

April 29, 2025 updated by: Bethan Phillips, University of Nottingham

The Effect of Upper Limb Low-intensity Motor Control Training (uMCON) Program on Cognitive Function in Healthy Older Adults: A Pilot Study

This healthy volunteer intervention study is designed to evaluate the effectiveness of upper limb motor control training (uMCT) on physical and cognitive functions in older adults. The primary objectives of the study are twofold:

Assess the Impact on Physical and Neuromuscular Function: The study seeks to determine whether uMCT positively influences physical performance, including motor coordination and neuromuscular function, in older adults.

Assessment the Impact on Cognitive Function: The study aims to investigate whether uMCT enhances cognitive abilities in older adults.

In addition to these main goals, the study will also assess the feasibility and safety of implementing uMCT in an older adult population.

The main questions it aims to answer are:

Does uMCON training have a positive effect on physical function and neuromuscular function in older adults?

Does uMCON training have a positive effect on cognitive function in older adults? The researchers designed this study to show whether uMCON training works on physical function (balance, gait, and so on) and cognition in older adults.

Participants will come to Derby Royal Hospital Medical School to attend uMCON training three days a week for 1 month. They will attend pre-training, post-training, and follow-up (after 1 month) control assessment sessions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Experimental protocol

Participants:

This study will be carried out on 24 healthy participants (aged between 65-85 years), with an aim to recruit 50% males. Participants will be randomised (via sealed envelope) to the uMCT group or a no-intervention control group (PPI). Before enrolment on to the study, participants will complete a screening session which will include an electrocardiogram (ECG), blood pressure check, and general health questions, including previous medical history. This session will also provide potential participants an opportunity to ask any questions about the study that they may have after reading the participant information sheet (PIS). If an abnormal screening result is encountered, this will be discussed with the participant and their GP will be informed in writing. All participants will be informed in detail about the procedures and risks of the study via the PIS and the opportunity to ask questions, before their written informed consent is obtained.

Assessment sessions:

All participants will be requested to attend 3 assessment sessions, in addition to 4-weeks uMCT (3x/wk) for the intervention group. For participants in the PPI group (no intervention control group), they will also attend the research unit 3x/wk to participate in patient and public involvement (PPI) (in research) activities. These actives will include, as examples, discussion around the importance/relevance of upcoming studies, lay review of participant/patient facing documents, assistance with research dissemination. Given the primary endpoint of this study is cognition, this approach will mitigate the impact of any adaptation in the uMCT group being due to their regular in-person engagement with the research team as all participants will have this. It will also allow participants in the no-intervention group to feel that their time is productive and worthwhile.

The assessment sessions will take place:

  • before the intervention (V1),
  • after the 4-week intervention (V2),
  • and after 4-weeks de-training (V3) to determine any adaptation retention.

Each of these sessions will be identical and will comprise:PPI

  • Evaluation of cognitive function using MOCA, TMT and SCWT,
  • The nine-hole Peg Test to determine dexterity,
  • Isometric dynamometery to determine MVC for elbow flexion and knee extension (to assess non-joint specific adaptation),
  • Surface electromyography (sEMG) of the triceps brachii and intramusculer electromyography (iEMG) of vastus lateralis to determine muscle activation patterns (training specific and non-specific),
  • Simple (eyes open) and complex (eyes closed) balance tests,
  • Timed Up-and-Go (TUG) to determine mobility,
  • The Short Physcial Performace Battery (SPPB) to assess overall physical performance.

Each assessment session is expected to last a maximum of 3 hours, allowing sufficient time for explanation of each component at each visit.

Training Sessions:

uMCT will involve 3 sessions each week for 4 weeks based on elbow flexion. Each session will last ~20 minutes and will be fully supervised by a member of the research team. During each training session, participants will be asked to follow a sinusoidal force line on a screen by contracting their elbow flexors. Six to 10 different force tracking wave forms will be performed in each session at 10%, 25%, or 40% of MVC with an amplitude of ±2%, ±4%, or ±8%. Each wave form will last 20-30 seconds with 60 seconds of rest between each.

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

Study Contact Backup

Study Locations

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Willing and able to give informed consent for participation in the study

    • Aged between 65-85 years

Exclusion Criteria:

  • • Diagnosis of cognitive impairment

    • Current or recent (<5y) malignancy
    • History of or current psychiatric illness
    • History of or current neurological condition (e.g., epilepsy, Parkinsons disease, cerebrovascular disease)
    • Severe respiratory disease (e.g., uncontrolled asthma, COPD, pulmonary hypertension)
    • Active cardiovascular disease: Uncontrolled hypertension (BP>160/100mmHg); Recent (<12mo) cardiac event; Heart failure (Class III/IV); Significant arrhythmia; Unstable angina
    • Metabolic disease: Untreated hyper/hypo-parathyroidism; Cushing's disease; Type 1 or 2 diabetes
    • Significant musculoskeletal disorders (based on clinical opinion)
    • Family history of early (<55y) death from cardiovascular disease

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
uMCON training group
Other: Upper limb motor control training (uMCON)
The exercise program protocol was determined using elbow flexion (Biceps brachii) and elbow extension (Triceps) on a special platform developed for the arm. In this computer-based exercise, participants are asked to follow a small ball on the screen in different lines at certain percentages of maximum muscle strength (10%, 25%, 50%, and so on). Neuromuscular training will be worked on with this exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome Measure Title: Rate of participants whose cognition improved with upper limb motor control training.
Time Frame: Baseline, 4 week, and 8 week
Number of Participants: 20 Control group: No Rate of Female/Male: 50%/ 50% Time frame: 1 month upper limb neuromuscular training Assessment time: Pre-training, Post-training, Follow-up(after 4 weeks) Cognition questionnaire is used (MOCA).
Baseline, 4 week, and 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically relevant functional outcomes (motor control, strength, dexterity, overall physical function)
Time Frame: Baseline, 4 week, and 8 week
  • The nine-hole Peg Test to determine dexterity,
  • Isometric dynamometery to determine MVC for elbow flexion and knee extension (to assess non-joint specific adaptation),
  • Surface electromyography (sEMG) of the triceps brachii and intramusculer electromyography (iEMG) of vastus lateralis to determine muscle activation patterns (training specific and non-specific),
  • Simple (eyes open) and complex (eyes closed) balance tests,
  • Timed Up-and-Go (TUG) to determine mobility,
  • The Short Physcial Performace Battery (SPPB) to assess overall physical performance.
Baseline, 4 week, and 8 week
Plasma pro/anti-inflammatory cytokine levels
Time Frame: Baseline, 4 week, and 8 week
Only a single blood sample (<10ml) will be taken from participants at each assessment session via venepuncture. This will only be performed by an individual trained and competent in this technique. Blood samples will be centrifuged, and plasma stored at -20 to -80 degrees until batch-analysis at the end of the study.
Baseline, 4 week, and 8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Study Director: Mehmet C Yildirim, PhD, The University of Nottingham
  • Study Director: Hatice Sirin Ekici, PhD, The University of Nottingham

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 (Actual)

September 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 8, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMHS 331-0723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to personal (identifiable) information is limited only to research staff involved in the participation elements of this study, and to audit staff as detailed above.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Cognitive Impairment

Clinical Trials on Upper limb motor control training (uMCON)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe