Healthy AgingLEMCOANCT05745402
Longitudinal Study to Determine the Effectiveness of the Mobility Checkup for Older Adults
A study testing Mobility Checkup for older adults in people with Healthy Aging, run by College of St. Scholastica, Inc. at 1 site in United States.
Trial summary
The investigators are developing a new, preventative physical therapy model of care for older adults called Mobility Checkup (MC). Proposed as an annual visit, the MC includes measurement of physical performance and education regarding the importance of maintaining mobility for overall health. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Mobility Checkup for older adults
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 30 Jun 2024
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- Walk independently with or without an assistive device
Who cannot join
- Experiencing short-term condition affecting their mobility
- Cardiac procedure or myocardial infarction (heart attack) in the last 6 months
- Has a guardian who is responsible for their healthcare decisions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
College of St. Scholastica-Health Science Center
Duluth, Minnesota, 55812
Kathy King, BS, 218-723-6786, kking@css.edu
John D Borstad, 2187236523, jborstad1@css.edu
About this study
Official title: A Longitudinal Study of the Effectiveness of the Mobility Checkup for Older Adults: Feasibility in the 'Year 1' Cohort
The investigators are developing a new, preventative physical therapy model of care for older adults called Mobility Checkup (MC). Proposed as an annual visit, the MC includes measurement of physical performance and education regarding the importance of maintaining mobility for overall health. The purpose of this study is to determine the feasibility of and begin data collection for, a longitudinal study of the effectiveness of the Mobility Checkup with a small cohort. This activity will evaluate the feasibility of recruitment and implementation of this longitudinal effectiveness study.
Read the detailed description
Healthy aging is defined as "the process of developing and maintaining the functional ability that enables well-being in older age" and includes mobility. Mobility disability (i.e., the inability to walk 400 meters and climb a flight of stairs without assistance) is the most prevalent form of disability for older adults in the United States. Unlike blood pressure or body mass index, physical performance measures such as walking speed help identify and predict preclinical mobility disability, but are rarely used in routine medical care. This is a missed opportunity, particularly for older adults, who may experience a subtle decline in physical performance that leads to mobility disability.
The position of the American Physical Therapy Association is that all people should have an annual physical therapy visit to optimize movement and promote health, wellness, and fitness; and slow the progression of impairments of body functions and structures, activity limitations, and participation restrictions.
Recommendations support preventive care for maintaining mobility. However, a model of care specific to preventing mobility disability in older adults is not common practice. Evidence suggests routine screening can predict mobility disability in older adults and that activity-based interventions prevent it.
The is year 1 of a longitudinal study that will determine the feasibility of an effectiveness study of a Mobility Checkup, an annual preventive visit within a model of physical therapy care. The Mobility Checkup prioratizes educating older adults on the value of physical performance as an indicator of health and aims to maintain mobility and reduce mobility disability among participants. Ultimately, this new model of care could result in a cost-effective tool to establish baseline physical performance and identify and prevent preclinical and mobility disabilities in older adults.
- Conditions
- Healthy Aging
- Being tested
- Mobility Checkup for older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility Checkup for older adultsBehavioural
The Mobility Checkup (MC) for older adults is a 45-minute preventative physical therapy visit designed to maintain mobility during aging. It has two parts, measurement (25 minutes) and education (20 minutes). The 5 standardized measures of physical performance in the MC are Walking speed, single leg stance time (balance), Five rep sit to stand (muscular endurance, transitions), 6-meter walk test (general endurance), and Timed up from floor test (transitions). Participants are provided education structured into 4 elements. 1. They are told their performance scores 2. They are shown how their performance scores on each of the measures compare to age and sex-referenced normative values 3. They are provided information about what their performance predicts about their health 4. They are referred to an appropriate provider if there was a health or safety concern during their MC or they are educated to follow the recommendations for physical activity that are recommended by the CDC.
| Study group | Role | What they receive |
|---|---|---|
| Mobility Checkup Intervention | Experimental | 45-minute Mobility checkup that includes 5 physical performance measures and education based on outcomes compared to age and gender normative values. Receives: Behavioral: Mobility Checkup for older adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
LASA Physical Activity Questionnaire (LAPAQ)
Questionnaire designed to measure the amount of physical activity a person completed over the last two weeks.
Measured: one year
Secondary outcomes (1)
The 6-minute walk test
In the 6-minute walk test the distance in meters a person can walk in 6 minutes is measured as evidence of their endurance.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Feb 2023
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of St. Scholastica, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Borstad, College of St. Scholastica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745402
- Sponsor's protocol ID
- 1234
- Acronym
- LEMCOA
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lieberz D, Borgeson H, Dobson S, Ewings L, Johnson K, Klaysmat K, Schultz A, Tasson R, Borstad AL. A Physical Therapy Mobility Checkup for Older Adults: Feasibility and Participant Preferences From a Discrete Choice Experiment. J Patient Cent Res Rev. 2022 Jan 17;9(1):24-34. doi: 10.17294/2330-0698.1874. eCollection 2022 Winter.
PubMed 35111880
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of the Effectiveness of the Mobility Checkup for Older Adults: Feasibility in the 'Year 1' Cohort
- ClinicalTrials.gov ID
- NCT05745402
- Acronym / sponsor ID
- LEMCOA / 1234
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- College of St. Scholastica, Inc.University, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Feb 2023 (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 investigators are developing a new, preventative physical therapy model of care for older adults called Mobility Checkup (MC). Proposed as an annual visit, the MC includes measurement of physical performance and education regarding the importance of maintaining mobility for overall health. The purpose of this study is to determine the feasibility of and begin data collection for, a longitudinal study of the effectiveness of the Mobility Checkup with a small cohort. This activity will evaluate the feasibility of recruitment and implementation of this longitudinal effectiveness study.
Detailed description
Healthy aging is defined as "the process of developing and maintaining the functional ability that enables well-being in older age" and includes mobility. Mobility disability (i.e., the inability to walk 400 meters and climb a flight of stairs without assistance) is the most prevalent form of disability for older adults in the United States. Unlike blood pressure or body mass index, physical performance measures such as walking speed help identify and predict preclinical mobility disability, but are rarely used in routine medical care. This is a missed opportunity, particularly for older adults, who may experience a subtle decline in physical performance that leads to mobility disability.
The position of the American Physical Therapy Association is that all people should have an annual physical therapy visit to optimize movement and promote health, wellness, and fitness; and slow the progression of impairments of body functions and structures, activity limitations, and participation restrictions.
Recommendations support preventive care for maintaining mobility. However, a model of care specific to preventing mobility disability in older adults is not common practice. Evidence suggests routine screening can predict mobility disability in older adults and that activity-based interventions prevent it.
The is year 1 of a longitudinal study that will determine the feasibility of an effectiveness study of a Mobility Checkup, an annual preventive visit within a model of physical therapy care. The Mobility Checkup prioratizes educating older adults on the value of physical performance as an indicator of health and aims to maintain mobility and reduce mobility disability among participants. Ultimately, this new model of care could result in a cost-effective tool to establish baseline physical performance and identify and prevent preclinical and mobility disabilities in older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobility Checkup Intervention | Experimental | Behavioral: Mobility Checkup for older adults45-minute Mobility checkup that includes 5 physical performance measures and education based on outcomes compared to age and gender normative values. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 55 years of age or older
- Walk independently with or without an assistive device
Key exclusion criteria (3 listed)
- Experiencing short-term condition affecting their mobility
- Cardiac procedure or myocardial infarction (heart attack) in the last 6 months
- Has a guardian who is responsible for their healthcare decisions
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 |
|---|---|---|
| Mobility Checkup for older adultsThe Mobility Checkup (MC) for older adults is a 45-minute preventative physical therapy visit designed to maintain mobility during aging. It has two parts, measurement (25 minutes) and education (20 minutes). The 5 standardized measures of physical performance in the MC are Walking speed, single leg stance time (balance), Five rep sit to stand (muscular endurance, transitions), 6-meter walk test (general endurance), and Timed up from floor test (transitions). Participants are provided education structured into 4 elements. 1. They are told their performance scores 2. They are shown how their performance scores on each of the measures compare to age and sex-referenced normative values 3. They are provided information about what their performance predicts about their health 4. They are referred to an appropriate provider if there was a health or safety concern during their MC or they are educated to follow the recommendations for physical activity that are recommended by the CDC. | Behavioural | Mobility Checkup Intervention |
Primary outcome
LASA Physical Activity Questionnaire (LAPAQ)
Time frame: one year
Questionnaire designed to measure the amount of physical activity a person completed over the last two weeks.
1 secondary outcome
The 6-minute walk test
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Results publication: PubMed 35111880Lieberz D, Borgeson H, Dobson S, Ewings L, Johnson K, Klaysmat K, Schultz A, Tasson R, Borstad AL. A Physical Therapy Mobility Checkup for Older Adults: Feasibility and Participant Preferences From a Discrete Choice Experiment. J Patient Cent Res Rev. 2022 Jan 17;9(1):24-34. doi: 10.17294/2330-0698.1874. eCollection 2022 Winter.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility Checkup for older adults in people with Healthy Aging, run by College of St. Scholastica, Inc. 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra L Borstad, PhD (218-625-4938, aborstad@css.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LASA Physical Activity Questionnaire (LAPAQ) (time frame: one year). 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 NCT05745402, which also lists 1 linked publication.
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 26 Sep 2023.