Last reviewed · How we verify

NCT04814459

Prevention Focused Home-Based Physical Therapy Utilizing Community Partnership Referrals

Completed NA Results posted Last updated 11 October 2021
What this trial tests

NA trial testing HOP-UP-PT Program in Fall in 144 participants. Completed in 15 May 2021.

Timeline
1 January 2019
Primary endpoint
15 May 2021
15 May 2021

Quick facts

Lead sponsorOakland University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment144
Start date1 January 2019
Primary completion15 May 2021
Estimated completion15 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Oakland University

Who can join

65 and older, any sex, with Fall or Risk Reduction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Reported Falls Primary · 7 months

Record of falls in prior year, and between each subsequent visit.

Baseline (All Participants)
GroupValue95% CI
HOP-UP-PT Program37
Normal Level of Activity34
Baseline (Moderat and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program29
Normal Level of Activity24
3 Month (All Participants)
GroupValue95% CI
HOP-UP-PT Program5
Normal Level of Activity3
3 Month (Moderate and Hight STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program5
Normal Level of Activity2
7 months (All Participants)
GroupValue95% CI
HOP-UP-PT Program7
Normal Level of Activity15
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program1
Normal Level of Activity11
Modified Short Physical Performance Battery (SPPB) Primary · 7 Months

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

Baseline (all participants)
GroupValue95% CI
HOP-UP-PT Program8.44± 2.66
Normal Level of Activity7.34± 2.85
Baseline (Moderate and high STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program7.64± 2.82
Normal Level of Activity6.18± 2.86
3 Month (all participants)
GroupValue95% CI
HOP-UP-PT Program9.29± 2.49
Normal Level of Activity8.04± 2.97
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program8.24± 2.43
Normal Level of Activity6.60± 2.95
7 Month (all participants)
GroupValue95% CI
HOP-UP-PT Program9.50± 2.22
Normal Level of Activity8.96± 2.63
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program7.64± 2.17
Normal Level of Activity7.25± 2.67
Timed Up and Go Primary · 7 Months

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.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program11.5± 4.6
Normal Level of Activity13.3± 6.0
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program12.9± 5.3
Normal Level of Activity15.7± 6.8
3 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program10.7± 3.7
Normal Level of Activity13.0± 6.3
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program12.0± 4.3
Normal Level of Activity15.4± 7.5
7 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program10.6± 3.7
Normal Level of Activity11.9± 5.4
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program13.8± 4.3
Normal Level of Activity14.6± 6.8
Stopping Elderly Accidents, Death & Injuries (STEADI) Fall Risk Categorization Primary · 7 Months

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,

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program0.8± 0.7
Normal Level of Activity0.7± 0.7
3 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program0.6± 0.7
Normal Level of Activity0.7± 0.6
7 Month (All Participants)
GroupValue95% CI
HOP-UP-PT Program0.4± 0.6
Normal Level of Activity0.6± 0.7
Stay Independent Questionnaire Secondary · 3 Months

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.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program4.8± 3.0
Normal Level of Activity4.7± 3.2
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program6.4± 2.7
Normal Level of Activity6.2± 2.5
3 Months (All participants)
GroupValue95% CI
HOP-UP-PT Program3.3± 2.9
Normal Level of Activity4.2± 2.8
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program5.0± 3.0
Normal Level of Activity5.2± 2.6
Modified Falls Efficacy Scale Secondary · 3 Months

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.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program9.2± 1.7
Normal Level of Activity9.0± 1.8
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program8.6± 1.8
Normal Level of Activity8.4± 2.3
3 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program9.7± 1.1
Normal Level of Activity9.2± 1.7
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program9.6± 1.2
Normal Level of Activity8.7± 2.1
Health Behavior Questionnaire Secondary · 3 Months

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

Baseline (All participants) Physical Activity
GroupValue95% CI
HOP-UP-PT Program2.0± 1.2
Normal Level of Activity1.9± 1.3
Baseline (All participants) Fruit and Vegetable Consumption
GroupValue95% CI
HOP-UP-PT Program2.2± 1.3
Normal Level of Activity2.4± 1.5
Baseline (All participants) Smoking Habits
GroupValue95% CI
HOP-UP-PT Program1.1± 0.5
Normal Level of Activity1.1± .04
Baseline (All participants) Recommended Weight
GroupValue95% CI
HOP-UP-PT Program2.2± 1.3
Normal Level of Activity2.2± 1.5
3 Month (All participants) Physical Activity
GroupValue95% CI
HOP-UP-PT Program1.7± 1.0
Normal Level of Activity2.2± 1.5
3 Month (All participants) Fruit and Vegetable
GroupValue95% CI
HOP-UP-PT Program2.0± 1.2
Normal Level of Activity2.2± 1.5
3 Month (All participants) Smoking
GroupValue95% CI
HOP-UP-PT Program1.0± 0.3
Normal Level of Activity1.1± 0.4
3 Month (All participants) Recommended Weight
GroupValue95% CI
HOP-UP-PT Program1.9± 1.2
Normal Level of Activity1.9± 1.2
Functional Comorbidity Index Secondary · 7 Months

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.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program4.0± 2.1
Normal Level of Activity3.9± 2.3
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program4.7± 2.1
Normal Level of Activity4.4± 2.4
3 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program4.1± 2.2
Normal Level of Activity4.5± 2.8
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program5.1± 2.43
Normal Level of Activity5.1± 3.3
7 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program3.8± 2.6
Normal Level of Activity4.0± 2.4
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program5.0± 1.0
Normal Level of Activity4.6± 2.8
Home Falls and Accidents Screening Tool (Home FAST) Secondary · 7 Months

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 circumstance

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program25.7± 6.2
Normal Level of Activity25.9± 7.8
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program25.5± 6.7
Normal Level of Activity24.9± 8.6
3 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program25.6± 5.7
Normal Level of Activity26.8± 7.3
3 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program25.4± 6.2
Normal Level of Activity26.3± 8.5
7 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program26.0± 5.0
Normal Level of Activity25.6± 5.9
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program26.9± 5.7
Normal Level of Activity23.4± 5.5
Body Mass Index Secondary · 7 Months

Assessment of body fat calculated from height and weight.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program29.9± 5.4
Normal Level of Activity28.6± 5.4
Baseline (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program30.2± 5.4
Normal Level of Activity29.2± 5.6
7 Month (All participants)
GroupValue95% CI
HOP-UP-PT Program29.5± 5.2
Normal Level of Activity35.1± 4.1
7 Month (Moderate and High STEADI Risk)
GroupValue95% CI
HOP-UP-PT Program32.7± 1.1
Normal Level of Activity30.9± 6.0
Blood Pressure Secondary · 7 Months

Assessment of mean resting blood pressure in seated position.

Baseline (All participants) Systolic
GroupValue95% CI
HOP-UP-PT Program133± 20
Normal Level of Activity131± 15
Baseline (All participants) Diastolic
GroupValue95% CI
HOP-UP-PT Program76± 10
Normal Level of Activity78± 10
Baseline (Moderate and High STEADI Risk) Systolic
GroupValue95% CI
HOP-UP-PT Program133± 22
Normal Level of Activity132± 15
Baseline (Moderate and High STEADI Risk) Diastolic
GroupValue95% CI
HOP-UP-PT Program76± 10
Normal Level of Activity79± 12
3 Month (All participants) Systolic
GroupValue95% CI
HOP-UP-PT Program125± 15
Normal Level of Activity125± 22
3 Month (All participants) Diastolic
GroupValue95% CI
HOP-UP-PT Program76± 15
Normal Level of Activity75± 10
3 Month (Moderate and High STEADI Risk) Systolic
GroupValue95% CI
HOP-UP-PT Program123± 13
Normal Level of Activity123± 21
3 Month (Moderate and High STEADI Risk) Diastolic
GroupValue95% CI
HOP-UP-PT Program74± 8
Normal Level of Activity74± 7
Number of Participants With Orthostatic Hypotension Secondary · 7 months

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.

Baseline (All participants)
GroupValue95% CI
HOP-UP-PT Program13
Normal Level of Activity16
Baseline (Moderate and High Fall Risk Participants)
GroupValue95% CI
HOP-UP-PT Program10
Normal Level of Activity12
3 Month (All Participants
GroupValue95% CI
HOP-UP-PT Program13
Normal Level of Activity7
3 Month (Moderate and High Fall Risk Participants)
GroupValue95% CI
HOP-UP-PT Program4
Normal Level of Activity3
7 Month (All Participants)
GroupValue95% CI
HOP-UP-PT Program10
Normal Level of Activity5
7 Month (Moderate and High Fall Risk Participants)
GroupValue95% CI
HOP-UP-PT Program4
Normal Level of Activity2

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Impact of the HOP-UP-PT program on older adults at risk to fall: a randomized controlled trial.
    Arena SK, Wilson CM, Boright L, Peterson E. · · 2021 · cited 13× · PMID 34598692 · DOI 10.1186/s12877-021-02450-0
  2. Medical Clearance of Older Adults Participating in Preventative Direct Access Physical Therapy.
    Arena SK, Wilson CM, Boright L, Webster O, et al · · 2023 · cited 2× · PMID 37025707 · DOI 10.7759/cureus.35784

Verify or expand the search:

Other recruiting trials for Fall

Currently open trials in the same condition.

Other Oakland University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04814459.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing