Physical ActivityNCT02044783
Identifying and Treating Physical Function Impairment in Elders
A study testing Behavioral Counseling in people with Physical Activity and Physical Impairment, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Physical Activity, Physical Impairment
- What is being tested?
- Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Who cannot join
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Read more
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
- Conditions
- Physical Activity, Physical Impairment
- Being tested
- Behavioral Counseling
- Keywords
- Adults, Elderly
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers Receives: Behavioral: Behavioral Counseling |
| Usual Care | No intervention | Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic). No behavioral counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical activity as determined by accelerometer
Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
Measured: 12 weeks
Changes in physical function as assessed by 400-meter walk speed
Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
Measured: 12 weeks
Changes in physical function as assessed by Short Physical Performance Battery
Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
Measured: 12 weeks
Change in physical function as assessed by lower extremity strength testing
Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
Measured: 12 weeks
Secondary outcomes (3)
Evaluation of standard implementation science process of reach
Reach is the percent of patients consented divided by the number eligible.
Measured: 1 year
Assessment of standard implementation science process metrics of acceptability
Acceptability will be assessed through structured surveys.
Measured: 1 year
Assessment of standard implementation science process metrics of implementation
Implementation process will be assessed by structured surveys
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Huebschmann, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044783
- Sponsor's protocol ID
- 13-3021
- Status last verified
- May 2018
- First submitted
- 22 Jan 2014
- Last updated
- 30 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Treating Physical Function Impairment in Elders
- ClinicalTrials.gov ID
- NCT02044783
- Acronym / sponsor ID
- 13-3021
- Conditions
- Physical Activity, Physical Impairment
- Keywords
- Adults, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Jan 2014 (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.
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention | Experimental | Behavioral: Behavioral CounselingBehavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers |
| Usual Care | No intervention | –Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic). No behavioral counseling. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Key exclusion criteria (6 listed)
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
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 |
|---|---|---|
| Behavioral Counseling | Behavioural | Behavioral Intervention |
Primary outcome
Changes in physical activity as determined by accelerometer
Time frame: 12 weeks
Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
Changes in physical function as assessed by 400-meter walk speed
Time frame: 12 weeks
Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
Changes in physical function as assessed by Short Physical Performance Battery
Time frame: 12 weeks
Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
Change in physical function as assessed by lower extremity strength testing
Time frame: 12 weeks
Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
3 secondary outcomes
Evaluation of standard implementation science process of reach
Time frame: 1 year
Assessment of standard implementation science process metrics of acceptability
Time frame: 1 year
Assessment of standard implementation science process metrics of implementation
Time frame: 1 year
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 30 May 2018.
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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.
Amy Huebschmann, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Counseling in people with Physical Activity and Physical Impairment, run by University of Colorado, Denver 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 1 inclusion and 6 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 30 May 2018. 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?
Changes in physical activity as determined by accelerometer (time frame: 12 weeks). The study lists 4 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 30 May 2018.