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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04814459
Other study ID # 912215-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date May 15, 2021

Study information

Verified date September 2021
Source Oakland University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This novel study supports the positive benefits of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) to older adults identified as "at-risk" by their local senior center after participating in a prevention-focused multimodal program provided by physical therapists in their home.


Description:

The purpose of this study was to describe the outcomes of Home Based Older Persons Upstreaming Physical Therapy (HOP-UP-PT) program participants and then to compare these outcomes to non-participants. 144 participants (n=72 per group) will be randomized to either the HOP-UP-PT intervention group or the Normal level of activity group. Six Michigan senior centers will refer adults ≥ 65 years who were at-risk for functional decline or falls. Licensed physical therapists will deliver physical, environmental, and health interventions within their approved scope of practice to the HOP-UP-PT intervention group during nine encounters (six in-person, three telerehabilitation) delivered over seven months. The Normal level of activity group participants are told to continue their usual physical activity routines during the same timeframe. Baseline and re-assessments are conducted at 0-, 3-, and 7-months for both the HOP-UP-PT intervention group and Normal level of activity group. Descriptions and comparisons from each assessment encounter will be analyzed.


Recruitment information / eligibility

Status Completed
Enrollment 144
Est. completion date May 15, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Greater than or equal to 65 years of age - Senior Community Center staff identified them as 'at-risk' for decline in community dwelling status due to physical, social, economic, or community-related barriers - Willingness to participate Exclusion Criteria: - Received physical therapy services within the prior two months in any setting - Had been hospitalized within the prior two months - Were currently receiving palliative or hospice care - Mini Cog score less than 4 and Trail Making Part B score greater than 273 seconds - Outcomes American College of Sports Medicine exercise pre-participation health screening indicating physician clearance needed for participation and after evaluation the physician will not clear

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HOP-UP-PT Program
Interventions provided to EG participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.

Locations

Country Name City State
United States Oakland University Rochester Michigan

Sponsors (2)

Lead Sponsor Collaborator
Oakland University Michigan Health Endowment Fund

Country where clinical trial is conducted

United States, 

References & Publications (20)

Adult BMI Calculator. Center for Disease Control and Prevention. Published 2020. Accessed January 25, 2021. https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_calculator/bmi_calculator.html

Arena SK, Wilson CM, Peterson E. Targeted Population Health Utilizing Direct Referral to Home-Based Older Person Upstreaming Prevention Physical Therapy From a Community-Based Senior Center. Cardiopulm Phys Ther J. 2020;31(1):11-21. doi:10.1097/CPT.0000000000000131

Black B, Marcoux BC, Stiller C, Qu X, Gellish R. Personal health behaviors and role-modeling attitudes of physical therapists and physical therapist students: a cross-sectional study. Phys Ther. 2012 Nov;92(11):1419-36. doi: 10.2522/ptj.20110037. Epub 2012 Jul 19. — View Citation

Campbell A RM. Otago Exercise Program to Prevent Falls in Older Adults. Otago Medical School, University of Otago. Accessed January 25, 2021. https://www.livestronger.org.nz/assets/Uploads/acc1162-otago-exercise-manual.pdf

Five Time Sit to Stand Test. Shirley Ryan Ability Lab. Published 2021. Accessed January 25, 2021. https://www.sralab.org/rehabilitation-measures/five-times-sit-stand-test

Four Stage Balance Test. Center for Disease Control and Prevention. Published 2017. Accessed January 25, 2021. https://www.cdc.gov/steadi/pdf/4-Stage_Balance_Test-print.pdf

Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. Erratum in: J Geriatr Phys Ther. 2009;32(3):110. — View Citation

Groll DL, To T, Bombardier C, Wright JG. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol. 2005 Jun;58(6):595-602. Review. — View Citation

Hill KD, Schwarz JA, Kalogeropoulos AJ, Gibson SJ. Fear of falling revisited. Arch Phys Med Rehabil. 1996 Oct;77(10):1025-9. — View Citation

Kyrdalen IL, Moen K, Røysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11. — View Citation

Macfarlane DJ, Chou KL, Cheng YH, Chi I. Validity and normative data for thirty-second chair stand test in elderly community-dwelling Hong Kong Chinese. Am J Hum Biol. 2006 May-Jun;18(3):418-21. — View Citation

Mackenzie L, Byles J, Higginbotham N. Reliability of the Home Falls and Accidents Screening Tool (HOME FAST) for identifying older people at increased risk of falls. Disabil Rehabil. 2002 Mar 20;24(5):266-74. — View Citation

Measuring orthostatic blood pressure. Center for Disease Control and Prevention. Published 2017. https://www.cdc.gov/steadi/materials.html

Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7. Review. — View Citation

Pignataro RM, Huddleston J. The Use of Motivational Interviewing in Physical Therapy Education and Practice: Empowering Patients Through Effective Self-Management. J Phys Ther Educ. 2015;29(2):62-71. doi:10.1097/00001416-201529020-00009

Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. — View Citation

STEADI: Algorithm for FallRisk Screening, Assessment, and Intervention. Center for Disease Control and Prevention. Published 2017. Accessed January 28, 2019. https://www.cdc.gov/steadi/materials.html

Tiedemann A, Shimada H, Sherrington C, Murray S, Lord S. The comparative ability of eight functional mobility tests for predicting falls in community-dwelling older people. Age Ageing. 2008 Jul;37(4):430-5. doi: 10.1093/ageing/afn100. Epub 2008 May 16. — View Citation

Wilson C, Arena SK, Starceski R, Swanson K. Older Adults' Outcomes and Perceptions After Participating in the HOP-UP-PT Program: A Prospective Descriptive Study. Home Healthc Now. 2020 Mar/Apr;38(2):86-91. doi: 10.1097/NHH.0000000000000843. — View Citation

Wilson CM, Arena SK, Adcock K, Colling D. A Home-Based Older Person Upstreaming Prevention Physical Therapy (HOP-UP-PT) Program Utilizing Community Partnership Referrals. Home Healthc Now. 2019 Mar/Apr;37(2):88-96. doi: 10.1097/NHH.0000000000000716. — View Citation

* Note: There are 20 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Reported Falls Record of falls in prior year, and between each subsequent visit. 7 months
Primary Modified Short Physical Performance Battery (SPPB) The Modified SPPB uses a 0-12 scale (0 = lowest function, 12 = highest function), calculated using collective outcomes of The Four Test Balance Scale (0= unable to perform, 1 = able to stand: feet together >10 sec, 2 = semi-tandem >10 sec, 4 = tandem stance >10 sec, higher score is better balance), 5 Time Sit to Stand (0 = >60 sec, 1=16.7 to 60 sec, 2 = 13.7 to 16.69 sec, 3 = 11.2 to 13.69 sec, and 4 = <11.19 sec, faster time is higher function), and the 3-meter gait speed test (0 = unable to perform, 1= > 6.52 sec, 2 = 4.66 to 6.52 sec, 3 = 3.62 to 4.65 sec, and 4 = < 3.62 sec, faster time is higher function). Each of the three categories has a highest score of 4 and are summed together for a highest total Modified SPPB score of 12. 7 Months
Primary Timed Up and Go The Timed Up and Go (TUG) is a times assessment of sit to stand transfer, 20 foot bought of ambulation with a 180 degree turn at 10 feet concluding with a stand to sit transfer. 7 Months
Primary Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization Low, moderate, and high risk was determined relative to results of the stay independent brochure, subjective report of falls and fall risk and brochure questions, as well as gait, strength, and balance assessment. The Stopping Elderly Accidents, Death & Injuries (STEADI) Algorithm underwent revisions since the study onset, the 2015 version was utilized as a guide for key outcome metrics reported in this study. Low STEADI risk =0, moderate STEADI risk =1, and high STEADI risk = 2. Low risk participants were categorized based on "no" responses to falls or fall risk questions as well as no gait, strength, or balance problems. Moderate risk participants were categorized by answering "yes" to key questions as well as demonstrating some gait, strength, or balance problems, and had a fall without injury. High risk participants were categorized by answering yes to key questions, demonstrating gait, strength, or balance problems, and had 2 or more falls or 1 fall with an injury. 7 Months
Secondary Stay Independent Questionnaire This questionnaire scores a fall risk on a scale from zero to 14, with 4 or more indicating a possible fall risk. Zero is the lowest fall risk score, 14 is a highest fall risk score. 3 Months
Secondary Modified Falls Efficacy Scale Measures fear of falling for 10 indoor and 4 outdoor activities. For each statement the participant circles a number that corresponds to their level of confidence, with zero being no confidence and 10 being extreme confidence. Once all 14 items are scored, they are added for a total score maximum of 140 which is then divided by 14. A number closer to 14 equates to more confidence, and a number closer to zero equates to less confidence. 3 Months
Secondary Health Behavior Questionnaire Assessment of current behaviors related to physical activity, consuming fruits and vegetables, not smoking, and being at a recommended weight. Patients are categorized using the five levels of the trans-theoretical model of behavior change. The pre-contemplating stage, or not ready for change is scored a 5. The contemplation stage or considering making a change in the next 6 months is scored a four. The preparation or preparing to make the change in the next 6 months is scored a 3. The action stage indicates the participant has made the change and is scored. The maintenance stage indicates the participants have maintained the change for at least 6 months and are scored a 1. 3 Months
Secondary Functional Comorbidity Index Self-assessment of disease comorbidity with physical function as the outcome. 18 diagnoses are listed and if the participant has been diagnosed with the condition it would be marked at a 1 and if they do not have the condition it would be marked as a zero. Zero would be the fewest amount of co-morbidities and 18 would be the highest amount of co-morbidities. 7 Months
Secondary Home Falls and Accidents Screening Tool (Home FAST) The tool evaluates 25 home safety domains and includes questions related to lighting, floor surfaces, and properly fitted foot wear. The original tool design was not scored but the investigators have added a scoring system (13 = safest environment to 50 = least safe environment) to quantify each question pertaining to the home environment. 13 home safety questions are scored as either Yes (indicating the recommended safety modifications was present) or No (indicating the recommended safety modifications had not been met). An additional 12 questions have an N/A option to be used in circumstances where a condition was not met (e.g., participant does not have a pet or stairs in the home). The investigators coded the responses as YES=1 point, NO= 2 points, an N/A= null within that category and not included during calculation. Therefore, overall Home FAST scores that decrease over time would suggest diminished home fall and accident risks related to their environment. 7 Months
Secondary Body Mass Index Assessment of body fat calculated from height and weight. 7 Months
Secondary Blood Pressure Assessment of mean resting blood pressure in seated position. 7 Months
Secondary Number of Participants With Orthostatic Hypotension Blood pressure was measured sequentially in supine, seated and standing and orthostatic hypotension was determined by the following parameters: a systolic blood pressure decrease of greater than or equal to 20 mm Hg or a diastolic blood pressure decrease of greater than or equal to 10 mm Hg between any of the three positions after three minutes in that position. 7 months
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