Gait, UnsteadyPRIMANCT02663778
Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults: Program to Improve Mobility in Aging
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
This randomized clinical trial targets 248 community-dwelling older adults with impaired mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training to a standard 12 week strength… 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
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2021
- 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.7
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 14Show 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
- fixed 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: Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults
This randomized clinical trial targets 248 community-dwelling older adults with impaired mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training to a standard 12 week strength, endurance and flexibility program. The primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent components of the intervention and measures of activity and participation. Delayed and sustained effects of the intervention are examined at 24 and 36 weeks.
Read the detailed description
Walking difficulty is common and costly in older adults. While traditional exercise has been shown to promote physical and mental health and may prevent walking difficulty, such exercise has focused on strength and endurance, and has overlooked a critical component of walking ability; the timing and coordination of movement. Aging and disease alter timing and coordination as reflected by slowed neuromotor performance, increased gait variability and reduced smoothness of movement. Task specific timing and coordination exercise that includes practice of smooth coordinated aspects of gait over multiple walking conditions has the potential to improve walking ability greater than a standard program. Our preliminary data suggest that interventions on timing and coordination of gait impact mobility greater than the standard strength and endurance program. The next key step and the objective of this proposal is to combine the two interventions to determine if potential gains in mobility, activity and participation obtained from a standard plus timing and coordination program, are larger than the gains obtained from the standard program alone. Therefore, the primary aim of the proposed project is to evaluate the impact of adding timing and coordination training to standard strength and endurance training on mobility. Secondary aims include examining 1) additional outcomes representing the components of the intervention and measures of activity and participation, 2) the delayed and sustained effects of the intervention, and 3) the effects of the intervention within various other subgroups of interest. This randomized clinical trial in 248 community-dwelling older adults who walk slowly (i.e. < 1.20 m/s) will compare a standard 12 week strength, endurance and flexibility program to a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training. The primary outcome is gait speed at 12 weeks. We will also examine secondary and tertiary outcomes representing components of the intervention and measures of activity and participation and the delayed and sustained effects at 24 and 36 weeks. The findings from this efficacy trial will provide evidence for the added value of task specific timing and coordination training for promoting walking ability in older adults and will form the basis for future effectiveness trials. Future work includes translation to nonprofessional exercise leaders with the long-term goal to incorporate neurological training into standard exercise programs for health promotion for older adults.
- Conditions
- Gait, Unsteady
- Being tested
- Strength training, Endurance training, Flexibility training, Task Specific timing and coordination training, Physical activity behavioral intervention
- 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
Task Specific timing and coordination trainingBehavioural
stepping and walking patterns to improve timing and coordination of gait
Physical activity behavioral interventionBehavioural
Intervention to encourage participants to be more physically active
| 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: Task Specific timing and coordination training; Behavioral: Physical activity behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Usual walking speed over a short distance. A physiologic measure recorded in m/s.
Measured: 12 weeks
Secondary outcomes (9)
Smoothness of walking
acceleration signal of usual walking. physiologic measure of the acceleration of walking.
Measured: 12, 24, and 36 weeks
gait variability
fluctuations in gait characteristics from step to step. physiologic measure of the spatial and temporal gait characteristics
Measured: 12, 24, 36 weeks
Late Life Function and Disability Instrument - function subscale
Self report measure of function
Measured: 12, 24, and 36 weeks
Late Life Function and Disability Instrument - disability subscale
Self report measure of disability
Measured: 12, 24, and 36 weeks
Lower extremity strength
physiologic measure of leg strength
Measured: 12, 24, and 36 weeks
Lower extremity muscle power
physiologic measure of leg muscle power
Measured: 12, 24, and 36 weeks
Six minute walk test
physiologic measure of walking endurance
Measured: 12, 24, and 36 weeks
Chair sit and reach test
physiologic measure of flexibility
Measured: 12, 24, and 36 weeks
Physical activity
Physiologic measure of physical activity measured using an accelerometer.
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 posted26 Jan 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer S. Brach, University of Pittsburgh
- Investigators
- Jennifer S Brach, PhD, PT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663778
- Sponsor's protocol ID
- PRO14080080
- Acronym
- PRIMA
- Status last verified
- Sep 2021
- First submitted
- 21 Jan 2016
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
VanSwearingen J, Perera S, Brach J. Effect of exercise on motor skill of walking among community-dwelling older adults: secondary outcomes of a randomized clinical trial. Age Ageing. 2026 Aug 3;55(10):afag312. doi: 10.1093/ageing/afag312.
PubMed 42912564Dunlap PM, Crane BM, Perera S, Moored KD, Carlson MC, Brach JS, Klatt BN, Rosso AL. Effects of a Physical Therapist Intervention on GPS Indicators of Community Mobility in Older Adults: A Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2023 Aug 1;103(8):pzad071. doi: 10.1093/ptj/pzad071.
PubMed 37364044Brach JS, Perera S, Shuman V, Gil AB, Kriska A, Nadkarni NK, Rockette-Wagner B, Cham R, VanSwearingen JM. Effect of Timing and Coordination Training on Mobility and Physical Activity Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212921. doi: 10.1001/jamanetworkopen.2022.12921.
PubMed 35604689
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults
- ClinicalTrials.gov ID
- NCT02663778
- Acronym / sponsor ID
- PRIMA / PRO14080080
- Conditions
- Gait, Unsteady
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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 randomized clinical trial targets 248 community-dwelling older adults with impaired mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training to a standard 12 week strength, endurance and flexibility program. The primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent components of the intervention and measures of activity and participation. Delayed and sustained effects of the intervention are examined at 24 and 36 weeks.
Detailed description
Walking difficulty is common and costly in older adults. While traditional exercise has been shown to promote physical and mental health and may prevent walking difficulty, such exercise has focused on strength and endurance, and has overlooked a critical component of walking ability; the timing and coordination of movement. Aging and disease alter timing and coordination as reflected by slowed neuromotor performance, increased gait variability and reduced smoothness of movement. Task specific timing and coordination exercise that includes practice of smooth coordinated aspects of gait over multiple walking conditions has the potential to improve walking ability greater than a standard program. Our preliminary data suggest that interventions on timing and coordination of gait impact mobility greater than the standard strength and endurance program. The next key step and the objective of this proposal is to combine the two interventions to determine if potential gains in mobility, activity and participation obtained from a standard plus timing and coordination program, are larger than the gains obtained from the standard program alone. Therefore, the primary aim of the proposed project is to evaluate the impact of adding timing and coordination training to standard strength and endurance training on mobility. Secondary aims include examining 1) additional outcomes representing the components of the intervention and measures of activity and participation, 2) the delayed and sustained effects of the intervention, and 3) the effects of the intervention within various other subgroups of interest. This randomized clinical trial in 248 community-dwelling older adults who walk slowly (i.e. < 1.20 m/s) will compare a standard 12 week strength, endurance and flexibility program to a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training. The primary outcome is gait speed at 12 weeks. We will also examine secondary and tertiary outcomes representing components of the intervention and measures of activity and participation and the delayed and sustained effects at 24 and 36 weeks. The findings from this efficacy trial will provide evidence for the added value of task specific timing and coordination training for promoting walking ability in older adults and will form the basis for future effectiveness trials. Future work includes translation to nonprofessional exercise leaders with the long-term goal to incorporate neurological training into standard exercise programs for health promotion for older adults.
Study design
- Primary purpose
- Treatment
- 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: Task Specific timing and coordination training, Behavioral: Physical activity behavioral interventionThe 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.7
Key exclusion criteria (14 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 |
| Task Specific timing and coordination trainingstepping and walking patterns to improve timing and coordination of gait | Behavioural | Standard-plus |
| Physical activity behavioral interventionIntervention to encourage participants to be more physically active | Behavioural | Standard, Standard-plus |
Primary outcome
Gait speed
Time frame: 12 weeks
Usual walking speed over a short distance. A physiologic measure recorded in m/s.
9 secondary outcomes
Smoothness of walking
Time frame: 12, 24, and 36 weeks
gait variability
Time frame: 12, 24, 36 weeks
Late Life Function and Disability Instrument - function subscale
Time frame: 12, 24, and 36 weeks
Late Life Function and Disability Instrument - disability subscale
Time frame: 12, 24, and 36 weeks
Lower extremity strength
Time frame: 12, 24, and 36 weeks
Lower extremity muscle power
Time frame: 12, 24, and 36 weeks
Six minute walk test
Time frame: 12, 24, and 36 weeks
Chair sit and reach test
Time frame: 12, 24, and 36 weeks
Physical activity
Time frame: 12, 24, and 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Derived from this study: PubMed 42912564VanSwearingen J, Perera S, Brach J. Effect of exercise on motor skill of walking among community-dwelling older adults: secondary outcomes of a randomized clinical trial. Age Ageing. 2026 Aug 3;55(10):afag312. doi: 10.1093/ageing/afag312.
- Derived from this study: PubMed 37364044Dunlap PM, Crane BM, Perera S, Moored KD, Carlson MC, Brach JS, Klatt BN, Rosso AL. Effects of a Physical Therapist Intervention on GPS Indicators of Community Mobility in Older Adults: A Secondary Analysis of a Randomized Controlled Trial. Phys Ther. 2023 Aug 1;103(8):pzad071. doi: 10.1093/ptj/pzad071.
- Derived from this study: PubMed 35604689Brach JS, Perera S, Shuman V, Gil AB, Kriska A, Nadkarni NK, Rockette-Wagner B, Cham R, VanSwearingen JM. Effect of Timing and Coordination Training on Mobility and Physical Activity Among Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212921. doi: 10.1001/jamanetworkopen.2022.12921.
- Individual participant dataSharing planned: Undecided
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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.
Jennifer S Brach, PhD, PT 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 14 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: finished, as of the sponsor's last update on 20 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gait speed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663778, which also lists 3 linked publications.
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 20 Sep 2021.