Gait, UnsteadyPRIMA-NIRSNCT04302831
Restoring Central Motor Control Extension
A study testing Strength training, Endurance training and Flexibility training in people with Gait, Unsteady, run by University of Pittsburgh at 1 site in United States.
Trial summary
Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait, Unsteady
- What is being tested?
- Strength training, Endurance training and Flexibility training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2020to 1 Dec 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age and older
- Ambulatory without an assistive device or the assistance of another person
- Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s
- Physician clearance to participate in a moderate intensity exercise program
- Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.
Who cannot join
- persistent lower extremity pain that is present on most days of the week
- back pain that is present on most days of the weeks and interferes with walking and - activities of daily living or back pain that increases with walking
- refuse to walk on a treadmill
- plans to move out of the area in the next 5 years
- dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
- any acute illness or medical condition that is not stable according to the approving physician
Show all 13Show fewer
- resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute
- diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination <79
- hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
- severe visual impairment f- ixed or fused lower extremity joints such as hip, knee or ankle
- lower extremity strength <3/5 on manual muscle testing
- lower extremity amputation
- progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: Restoring Central Motor Control to Improve Community Mobility of Older Adults
Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.
- Conditions
- Gait, Unsteady
- Being tested
- Strength training, Endurance training, Flexibility training, Physical activity behavioral intervention, Task Specific timing and coordination training
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
weight lifting to increase muscle strength
Endurance trainingBehavioural
treadmill walking to increase endurance
Flexibility trainingBehavioural
stretches to improve flexibility
Physical activity behavioral interventionBehavioural
Intervention to encourage participants to be more physically active
Task Specific timing and coordination trainingBehavioural
stepping and walking patterns to improve timing and coordination of gait
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. Receives: Behavioral: Strength training; Behavioral: Endurance training; Behavioral: Flexibility training; Behavioral: Physical activity behavioral intervention |
| Standard-plus | Experimental | The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. Receives: Behavioral: Strength training; Behavioral: Endurance training; Behavioral: Flexibility training; Behavioral: Physical activity behavioral intervention; Behavioral: Task Specific timing and coordination training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
Measured: change from baseline to 12 weeks
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
Measured: change from baseline to 36 weeks
Secondary outcomes (6)
Gait speed
Walking speed (m/s) during usual pace
Measured: 12, 24, and 36 weeks
Gait speed
Walking speed (m/s) with a cognitive challenge.
Measured: 12, 24, and 36 weeks
Gait speed
Walking speed (m/s) on an uneven surface.
Measured: 12, 24, and 36 weeks
Gait variability
Fluctuations in gait characteristics from step to step during usual pace. Physiologic measure of temporal gait characteristics (standard deviation).
Measured: 12, 24, and 36 weeks
Gait variability
Fluctuations in gait characteristics from step to step while walking with a cognitive challenge. Physiologic measure of temporal gait characteristics (standard deviation).
Measured: 12, 24, and 36 weeks
Gait variability
Fluctuations in gait characteristics from step to step while walking on an uneven surface. Physiologic measure of temporal gait characteristics (standard deviation).
Measured: 12, 24, and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start4 Mar 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: COVID-19 safety restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, UnsteadyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Andrea Rosso, University of Pittsburgh
- Investigators
- Andrea L Rosso, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302831
- Sponsor's protocol ID
- STUDY19110142
- Other IDs
- R01AG057671-01A1
- Acronym
- PRIMA-NIRS
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Central Motor Control to Improve Community Mobility of Older Adults
- ClinicalTrials.gov ID
- NCT04302831
- Acronym / sponsor ID
- PRIMA-NIRS / STUDY19110142
- Conditions
- Gait, Unsteady
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19 safety restrictions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 10 Mar 2020 (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.
Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Strength training, Behavioral: Endurance training, Behavioral: Flexibility training, Behavioral: Physical activity behavioral interventionThe standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. |
| Standard-plus | Experimental | Behavioral: Strength training, Behavioral: Endurance training, Behavioral: Flexibility training, Behavioral: Physical activity behavioral intervention, Behavioral: Task Specific timing and coordination trainingThe standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65 years of age and older
- Ambulatory without an assistive device or the assistance of another person
- Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s
- Physician clearance to participate in a moderate intensity exercise program
- Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.
Key exclusion criteria (13 listed)
- persistent lower extremity pain that is present on most days of the week
- back pain that is present on most days of the weeks and interferes with walking and - activities of daily living or back pain that increases with walking
- refuse to walk on a treadmill
- plans to move out of the area in the next 5 years
- dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
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 |
|---|---|---|
| Strength trainingweight lifting to increase muscle strength | Behavioural | Standard, Standard-plus |
| Endurance trainingtreadmill walking to increase endurance | Behavioural | Standard, Standard-plus |
| Flexibility trainingstretches to improve flexibility | Behavioural | Standard, Standard-plus |
| Physical activity behavioral interventionIntervention to encourage participants to be more physically active | Behavioural | Standard, Standard-plus |
| Task Specific timing and coordination trainingstepping and walking patterns to improve timing and coordination of gait | Behavioural | Standard-plus |
Primary outcome
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Time frame: change from baseline to 12 weeks
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking
Time frame: change from baseline to 36 weeks
Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).
6 secondary outcomes
Gait speed
Time frame: 12, 24, and 36 weeks
Gait speed
Time frame: 12, 24, and 36 weeks
Gait speed
Time frame: 12, 24, and 36 weeks
Gait variability
Time frame: 12, 24, and 36 weeks
Gait variability
Time frame: 12, 24, and 36 weeks
Gait variability
Time frame: 12, 24, and 36 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Andrea L Rosso, PhD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training, Endurance training and Flexibility training in people with Gait, Unsteady, run by University of Pittsburgh 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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 16 Mar 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking (time frame: change from baseline to 12 weeks). The study lists 2 primary outcomes in all. 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 16 Mar 2021.