Mobility LimitationEarly Phase 1NCT04446455
A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
A Early Phase 1 study testing InVEST: Increased Velocity Exercise Specific to Task and TAPAT: Tonic and Phasic Alertness Training in people with Mobility Limitation, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- InVEST: Increased Velocity Exercise Specific to Task and TAPAT: Tonic and Phasic Alertness Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 15 Nov 2018
- Phase
- Early Phase 1
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-90
- History of fall in the past year OR difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks)
- Community Dwelling
- Ability to speak and understand English
Who cannot join
- Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer
- Major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen
- Myocardial infarction or major surgery in previous 3 months
- Planned major surgery (e.g. joint replacement)
- Baseline Short Physical Performance Battery Score <4 or >10
- Modified Mini Mental Status Examination score of ≤77 out of 100
- Inability to safely complete the 400 meter walk test
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care Veterans 65 years and older.
Read the detailed description
This study is a randomized control pilot study. All participants will receive rehabilitative exercise addressing mobility skills. In addition, one group will be will receive additional cognitive training. Randomization is stratified according to screening mobility and cognitive score.
- Conditions
- Mobility Limitation
- Being tested
- InVEST: Increased Velocity Exercise Specific to Task, TAPAT: Tonic and Phasic Alertness Training
- Keywords
- Rehabilitation, Aging, Mobility Skills, Cognitive Training
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InVEST: Increased Velocity Exercise Specific to TaskOther
Functional Power Training
TAPAT: Tonic and Phasic Alertness TrainingOther
Computerized cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Functional Power + Cognitive Training | Experimental | Training sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training. Receives: Other: InVEST: Increased Velocity Exercise Specific to Task; Other: TAPAT: Tonic and Phasic Alertness Training |
| Functional Power Training | Active comparator | Training sessions began with 40 minutes of functional power training. Receives: Other: InVEST: Increased Velocity Exercise Specific to Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
Measured: Baseline, 6 weeks
Secondary outcomes (8)
Change from Baseline Figure-of-8 Performance 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline 400 Meter Walk Test at 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
Range: 0-12; higher score better physical performance
Measured: Baseline, 6 weeks
Change from Baseline Cognitive Performance at 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline Trail Making Test at 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline Clock-in-the-Box Test at 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline Letter Fluency Test at 6 weeks
Measured: Baseline, 6 weeks
Change from Baseline Hopkins Verbal Learning Test at 6 weeks
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 May 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility LimitationStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Pilot Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jonathan F. Bean, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446455
- Sponsor's protocol ID
- 3014
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot to Evaluate the Feasibility and Efficacy of a Multifaceted Rehabilitation Intervention
- ClinicalTrials.gov ID
- NCT04446455
- Acronym / sponsor ID
- 3014
- Conditions
- Mobility Limitation
- Keywords
- Rehabilitation, Aging, Mobility Skills, Cognitive Training
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 25 Jun 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.
The goal of this study is to evaluate the efficacy of multifaceted rehabilitation program in Veterans 65 years and older. This study will also examine the neuromuscular and cognitive attributes that contribute to clinically meaningful improvements in mobility; and determine whether a novel mode of cognitive training can enhance cognition among mobility limited primary care Veterans 65 years and older.
Detailed description
This study is a randomized control pilot study. All participants will receive rehabilitative exercise addressing mobility skills. In addition, one group will be will receive additional cognitive training. Randomization is stratified according to screening mobility and cognitive score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Functional Power + Cognitive Training | Experimental | Other: InVEST: Increased Velocity Exercise Specific to Task, Other: TAPAT: Tonic and Phasic Alertness TrainingTraining sessions began with approximately 30 minutes of cognitive training using a desktop computer followed by 40 minutes of functional power training. |
| Functional Power Training | Active comparator | Other: InVEST: Increased Velocity Exercise Specific to TaskTraining sessions began with 40 minutes of functional power training. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65-90
- History of fall in the past year OR difficulty or task modification with climbing one flight of stairs or walking ½ mile (6 blocks)
- Community Dwelling
- Ability to speak and understand English
Key exclusion criteria (7 listed)
- Presence of a terminal disease (e.g. receiving hospice services, metastatic cancer
- Major medical problem interfering with safe and successful testing (i.e. history of hip replacement with recurrent dislocation; uncontrolled hypertension, use of supplemental oxygen
- Myocardial infarction or major surgery in previous 3 months
- Planned major surgery (e.g. joint replacement)
- Baseline Short Physical Performance Battery Score <4 or >10
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 |
|---|---|---|
| InVEST: Increased Velocity Exercise Specific to TaskFunctional Power Training | Other | Functional Power + Cognitive Training, Functional Power Training |
| TAPAT: Tonic and Phasic Alertness TrainingComputerized cognitive training. | Other | Functional Power + Cognitive Training |
Primary outcome
Change from Baseline Late-Life Function and Disability Instrument at 6 weeks
Time frame: Baseline, 6 weeks
Function domain and the advanced and basic lower extremity function sub-domains of the Late-Life Function and Disability Instrument
8 secondary outcomes
Change from Baseline Figure-of-8 Performance 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline 400 Meter Walk Test at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Short Physical Performance Battery (SPPB) at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Cognitive Performance at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Trail Making Test at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Clock-in-the-Box Test at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Letter Fluency Test at 6 weeks
Time frame: Baseline, 6 weeks
Change from Baseline Hopkins Verbal Learning Test at 6 weeks
Time frame: Baseline, 6 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 25 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing InVEST: Increased Velocity Exercise Specific to Task and TAPAT: Tonic and Phasic Alertness Training in people with Mobility Limitation, run by VA Boston Healthcare System 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 4 inclusion and 7 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 25 Jun 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from Baseline Late-Life Function and Disability Instrument at 6 weeks (time frame: Baseline, 6 weeks). 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 25 Jun 2020.