Age-related Mobility DeclineNCT02554916
Locomotor Adaptation Training to Prevent Mobility Disability
An observational study of Age-related Mobility Decline, run by University of Florida at 1 site in United States.
Trial summary
This is an exploratory study designed to investigate the effects of aerobic dual belt treadmill walking versus traditional treadmill exercise on gait performance and functional capacity in older adults at risk for mobility disability. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Mobility Decline
- What is being tested?
- Dual-Belt Exercise, Treadmill Exercise and Dual-Belt Treadmill
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 17 Jul 2019
- Phase
- Observational
- 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
Study population: Older adults with sedentary lifestyle willing to be be randomized to and treatment groups.
Who may be able to join
- Age 65 and older
- Gait Speed of ≤ 1m/s
- Summary score 7-10 on the Short Physical Performance Battery, indicating mild to moderate impairment
- Sedentary as defined by reporting <20 min/wk of performing regular physical activity in the past month and <125 min/wk of moderate physical activity on the CHAMPS-18 questionnaire
- Willingness to be randomized to any of the treatment groups
Who cannot join
- Failure to provide informed consent
- Planned surgery in next year
- Hospitalization within the past 6 months
- Smoker > 1 pack per day
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Modified Mini-Mental State score <24
- Significant cognitive executive impairment, defined as a Montreal Cognitive Assessment (MoCA) score of<25
Show all 16Show fewer
- Progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, Amyotrophic lateral sclerosis (ALS)
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
- Terminal illness with life expectancy less than 12 mos, as determined by a physician
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
- Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina;
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (>14 drinks per wk); persons with depression will not be excluded
- Develops chest pain or severe shortness of breath during exercise test
- Unable to communicate because of severe hearing loss or speech disorder or language barrier
- Lives outside of the study site or is planning to move out of the area in next year or leave the area for >1 month during the next year
- Severe diabetes, requiring use of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Rehabilitation Interventions for Mobility Impairment in Parkinson's Disease
This is an exploratory study designed to investigate the effects of aerobic dual belt treadmill walking versus traditional treadmill exercise on gait performance and functional capacity in older adults at risk for mobility disability. Identifying the relationship between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking abilities will serve to optimize current rehabilitation approaches.
Read the detailed description
Participants will be forty-eight older adults with pre-clinical mobility disability who will be randomized into one of three intervention groups: dual-belt treadmill exercise, traditional treadmill exercise, or non-contact control.
Prior to and following 16 weeks of therapy, we will observe the participants' performing several functional movements (walking, standing from sitting, sitting from standing, walking up and down stairs) and measure their muscular activity. These performance-based measures will be obtained to determine whether their movement function improves as a result of therapeutic intervention. The participants' absolute performance on any of these tasks does not matter as much as that they make the very best effort on each of the tests. They are welcome to take a break at any point in the testing or training.
- Conditions
- Age-related Mobility Decline
- Being tested
- Dual-Belt Exercise, Treadmill Exercise, Usual Care, Dual-Belt Treadmill
- Keywords
- Mobility decline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Belt ExerciseBehavioural
Also called Dual-Belt Treadmill
The dual-belted exercise treadmill can control the speeds of the right and left legs individually. When asymmetric, the dual-belt treadmill imposes mechanical and sensory perturbations independently to each leg such that the central nervous system (CNS) must solve and adapt to the challenge to maintain walking.
Treadmill ExerciseBehavioural
The treadmill exercise will maintain the speed of the right and left leg together while walking.
Usual CareOther
This group will not be assigned to a treadmill but is as a non-exercising control group.
Dual-Belt TreadmillDevice
| Study group | Role | What they receive |
|---|---|---|
| Dual-belt Exercise | The participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks. Receives: Behavioral: Dual-Belt Exercise; Device: Dual-Belt Treadmill | |
| Treadmill Exercise | The participants assigned to this group will use the treadmill 3 times a week for 16 weeks. Receives: Behavioral: Treadmill Exercise; Device: Dual-Belt Treadmill | |
| Usual Care | The participants assigned to this group will not use the treadmills. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed
Gait speed will be determined from kinematic and kinetic measurement methods. A low value would indicate a slower walking speed compared to a higher value (faster walking speed).
Measured: baseline and up to 6 weeks following the intervention
Change in temporal variability
Temporal will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.
Measured: baseline and up to 6 weeks following the intervention
Change in spatial variability
Spatial will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.
Measured: baseline and up to 6 weeks following the intervention
Secondary outcomes (12)
Change in physical performance
Using the Short Physical Performance Battery. A score is generated from 0 (worst performance)-12 (best performance).
Measured: baseline and up to 6 weeks following the intervention
Change in cognitive impairment
Using the Mini Mental State Exam. Each item has 5 possible points. Scores greater than or equal to 27 (out of 30) indicates normal cognition. Severe = <9, moderate = 10-18, and mild = 19-24 cognitive impairment.
Measured: baseline and up to 6 weeks following the intervention
Change in Cognitive impairment of executive function
Using the Montreal Cognitive assessment. 30 items. A score of less than 26 on this assessment will indicate cognitive executive function.
Measured: baseline and up to 6 weeks following the intervention
Change in Disability
The Pepper Assessment Tool for Disability will be used. Includes 5 subscales: mobility, transferring, upper extremity, instrumental and basic activities of daily living.
Low scores indicate higher functioning and high independence. The Late-life function and Disability instrument will also be used. This has a 16-item disability component and a 32-item function component. Items are scored for 1-5 for function and 1-5 for frequency and extent of disability. Where high scores in frequency would represent more activity, and low scores in disability would represent less disabled.
Measured: baseline and up to 6 weeks following the intervention
Change in likelihood of falling
Using the Dynamic Gait Index. This is an observational task that is scored on an ordinal scale. Total score per item is summed to a total score from 0(low level of function, high likelihood of falling)-24(high level of function, low likelihood of falling).
Measured: baseline and up to 6 weeks following the intervention
Change in knee extensor strength
Using an isokinetic dynamometer, we will test Knee extensor strength. Peak torque will be calculated. A high value indicates more strength. Low values indicate less strength.
Measured: baseline and up to 6 weeks following the intervention
Change in ankle plantarflexor strength
Using an isokinetic dynamometer, we will test ankle plantarflexor strength. Peak torque will be calculated. A high value indicates more strength. Low values indicate less strength.
Measured: baseline and up to 6 weeks following the intervention
Change in Timed up and Go
Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Measured: baseline and up to 6 weeks following the intervention
Change in timed chair rise
Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Measured: baseline and up to 6 weeks following the intervention
Change in timed stair climb
Participants will be timed in seconds. More time to complete the task indicates low function, while less time indicates high function.
Measured: baseline and up to 6 weeks following the intervention
Change in energetic cost of walking
This will be measured by: electrocardiogram, blood pressure, spirometry tests, and ratings of perceived exertion.
The participant's maximal aerobic fitness, or oxygen consumption (VO2max) will be determined using a walking symptom-limited graded exercise test (GXT; modified walking incremental treadmill Naughton). All tests will follow the guidelines of the American College of Sports Medicine (ACSM) with electrocardiogram (ECG) heart monitoring and periodic blood pressure measures. Open-circuit spirometry will be used to determine VO2max and carbon dioxide production. Walking time until voluntary exhaustion or pain limitation will be recorded. Rating of perceived exertion (RPE) values will be collected at rest, at each exercise stage and during recovery. The treadmill tests will be performed at baseline and following the interventions.
Measured: baseline and up to 6 weeks following the intervention
Change in Ambulatory activity
7 day assessment using an activity monitor. The device will count the number of steps taken.
Measured: baseline and up to 6 weeks following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJul 2010
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Mobility DeclineStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chris J Hass, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554916
- Sponsor's protocol ID
- IRB201400915-N
- Other IDs
- 1R21AG048133-01A1
- Status last verified
- Jul 2019
- First submitted
- 17 Sep 2015
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rehabilitation Interventions for Mobility Impairment in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02554916
- Acronym / sponsor ID
- IRB201400915-N
- Conditions
- Age-related Mobility Decline
- Keywords
- Mobility decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2010
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 18 Sep 2015 (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 is an exploratory study designed to investigate the effects of aerobic dual belt treadmill walking versus traditional treadmill exercise on gait performance and functional capacity in older adults at risk for mobility disability. Identifying the relationship between aerobic treadmill exercise (dual belt or traditional) and the recovery of walking abilities will serve to optimize current rehabilitation approaches.
Detailed description
Participants will be forty-eight older adults with pre-clinical mobility disability who will be randomized into one of three intervention groups: dual-belt treadmill exercise, traditional treadmill exercise, or non-contact control.
Prior to and following 16 weeks of therapy, we will observe the participants' performing several functional movements (walking, standing from sitting, sitting from standing, walking up and down stairs) and measure their muscular activity. These performance-based measures will be obtained to determine whether their movement function improves as a result of therapeutic intervention. The participants' absolute performance on any of these tasks does not matter as much as that they make the very best effort on each of the tests. They are welcome to take a break at any point in the testing or training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual-belt Exercise | – | Behavioral: Dual-Belt Exercise, Device: Dual-Belt TreadmillThe participants assigned to this group will use the dual-belt treadmill 3 times a week for 16 weeks. |
| Treadmill Exercise | – | Behavioral: Treadmill Exercise, Device: Dual-Belt TreadmillThe participants assigned to this group will use the treadmill 3 times a week for 16 weeks. |
| Usual Care | – | Other: Usual CareThe participants assigned to this group will not use the treadmills. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults with sedentary lifestyle willing to be be randomized to and treatment groups.
Key inclusion criteria (5 listed)
- Age 65 and older
- Gait Speed of ≤ 1m/s
- Summary score 7-10 on the Short Physical Performance Battery, indicating mild to moderate impairment
- Sedentary as defined by reporting <20 min/wk of performing regular physical activity in the past month and <125 min/wk of moderate physical activity on the CHAMPS-18 questionnaire
- Willingness to be randomized to any of the treatment groups
Key exclusion criteria (16 listed)
- Failure to provide informed consent
- Planned surgery in next year
- Hospitalization within the past 6 months
- Smoker > 1 pack per day
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Modified Mini-Mental State score <24
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 |
|---|---|---|
| Dual-Belt ExerciseAlso: Dual-Belt TreadmillThe dual-belted exercise treadmill can control the speeds of the right and left legs individually. When asymmetric, the dual-belt treadmill imposes mechanical and sensory perturbations independently to each leg such that the central nervous system (CNS) must solve and adapt to the challenge to maintain walking. | Behavioural | Dual-belt Exercise |
| Treadmill ExerciseThe treadmill exercise will maintain the speed of the right and left leg together while walking. | Behavioural | Treadmill Exercise |
| Usual CareThis group will not be assigned to a treadmill but is as a non-exercising control group. | Other | Usual Care |
| Dual-Belt Treadmill | Device | Dual-belt Exercise, Treadmill Exercise |
Primary outcome
Change in Gait Speed
Time frame: baseline and up to 6 weeks following the intervention
Gait speed will be determined from kinematic and kinetic measurement methods. A low value would indicate a slower walking speed compared to a higher value (faster walking speed).
Change in temporal variability
Time frame: baseline and up to 6 weeks following the intervention
Temporal will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.
Change in spatial variability
Time frame: baseline and up to 6 weeks following the intervention
Spatial will be determined from kinematic and kinetic measurement methods. Lower values correspond to better walking performance.
12 secondary outcomes
Change in physical performance
Time frame: baseline and up to 6 weeks following the intervention
Change in cognitive impairment
Time frame: baseline and up to 6 weeks following the intervention
Change in Cognitive impairment of executive function
Time frame: baseline and up to 6 weeks following the intervention
Change in Disability
Time frame: baseline and up to 6 weeks following the intervention
Change in likelihood of falling
Time frame: baseline and up to 6 weeks following the intervention
Change in knee extensor strength
Time frame: baseline and up to 6 weeks following the intervention
Change in ankle plantarflexor strength
Time frame: baseline and up to 6 weeks following the intervention
Change in Timed up and Go
Time frame: baseline and up to 6 weeks following the intervention
Change in timed chair rise
Time frame: baseline and up to 6 weeks following the intervention
Change in timed stair climb
Time frame: baseline and up to 6 weeks following the intervention
Change in energetic cost of walking
Time frame: baseline and up to 6 weeks following the intervention
Change in Ambulatory activity
Time frame: baseline and up to 6 weeks following the intervention
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 22 Jul 2019.
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.
Chris J Hass, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Mobility Decline, run by University of Florida 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 16 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 22 Jul 2019. 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?
Change in Gait Speed (time frame: baseline and up to 6 weeks following the intervention). The study lists 3 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 22 Jul 2019.