Cognitive ImpairmentuMCONNCT06962722
The Effect of Upper Limb Low-intensity Motor Control Training Program on Cognitive Function in Healthy Older Adults
A study of Cognitive Impairment, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- • Willing and able to give informed consent for participation in the study
- Aged between 65-85 years
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jemima Collins, Assist Prof contact
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Nottingham Medical School
Derby, Derbyshire, DE22 3DT
Bethan E Phillips, Professor, beth.phillips@nottingham.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Upper limb motor control training (uMCON)
- Keywords
- neuromuscular training, older adults, cognitive impairment, exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb motor control training (uMCON)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | uMCON training group Receives: Other: Upper limb motor control training (uMCON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure Title: Rate of participants whose cognition improved with upper limb motor control training.
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).
Measured: Baseline, 4 week, and 8 week
Secondary outcomes (2)
Clinically relevant functional outcomes (motor control, strength, dexterity, overall physical function)
- 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.
Measured: Baseline, 4 week, and 8 week
Plasma pro/anti-inflammatory cytokine levels
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.
Measured: Baseline, 4 week, and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Sep 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethan Phillips, University of Nottingham
- Investigators
- Hatice Sirin Ekici, PhD, Study director, The University of NottinghamMehmet C Yildirim, PhD, Study director, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962722
- Sponsor's protocol ID
- FMHS 331-0723
- Acronym
- uMCON
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Limb Low-intensity Motor Control Training (uMCON) Program on Cognitive Function in Healthy Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT06962722
- Acronym / sponsor ID
- uMCON / FMHS 331-0723
- Conditions
- Cognitive Impairment
- Keywords
- neuromuscular training, older adults, cognitive impairment, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 May 2025 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Upper limb motor control training (uMCON)uMCON training group |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- • Willing and able to give informed consent for participation in the study
Key exclusion criteria (9 listed)
- • Diagnosis of cognitive impairment
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 |
|---|---|---|
| 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. | Other | Intervention Group |
Primary outcome
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).
2 secondary outcomes
Clinically relevant functional outcomes (motor control, strength, dexterity, overall physical function)
Time frame: Baseline, 4 week, and 8 week
Plasma pro/anti-inflammatory cytokine levels
Time frame: Baseline, 4 week, and 8 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No. 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.
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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.
Jemima Collins, Assist Prof contact
Hatice Sirin Ekici, PhD study director
The University of Nottingham
Mehmet C Yildirim, PhD study director
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cognitive Impairment, run by University of Nottingham at 1 site in United Kingdom.
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 9 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: looking for participants now, as of the sponsor's last update on 8 May 2025. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bethan E Phillips, Professor (01332 724676, beth.phillips@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure Title: Rate of participants whose cognition improved with upper limb motor control training. (time frame: Baseline, 4 week, and 8 week). 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 8 May 2025.