Frail Older AdultsNCT01872637
Improving Function, Participation and Function After Acute Hospitalization in Older Adults
A study testing Progressive Multi-Component Intervention in people with Frail Older Adults, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Older Adults
- What is being tested?
- Progressive Multi-Component Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to May 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years or older
- referred to home care physical therapy
- have at least 3 comorbid conditions
- ambulatory without human assistance prior to hospitalization
Who cannot join
- acute lower extremity fractures with weight-bearing restriction
- elective joint replacement surgery
- active cancer diagnosis
- acute cardiac surgery
- lower extremity amputation
- referred to hospice home health physical therapy
- dialysis
- hospice care
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver, Anschutz Medical Campus
Aurora, Colorado, 80045
Arcadia University
Glenside, Pennsylvania, 19038
About this study
Official title: Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial
Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. The proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. If successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.
Read the detailed description
Background: Hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. No studies have examined the effectiveness of Home Health (HH) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. Our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. This intervention is designed to work within the existing Medicare system and has potential for immediate clinical impact.
Purpose: The primary aim of our study is to determine if a progressive multi-component (PMC) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (UC) physical therapy. We hypothesize that there will be a greater improvement in gait speed measured for the PMC group compared to the UC group following one episode of care. Benefits of PMC will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint).
Design: We propose to conduct a single blind randomized two arm clinical trial (RCT) in older adults discharged from acute care and referred to HH physical therapy. Both interventions (PMC \& UC) will be Medicare-reimbursed. All assessments and interventions will occur in the patients' homes.
Methods: Twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.
- Conditions
- Frail Older Adults
- Being tested
- Progressive Multi-Component Intervention, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Multi-Component InterventionBehavioural
Usual CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Progressive Multi-Component Intervention | Experimental | Patients in this exercise group will receive 10-18, 45-60 minute, physical therapy visits in their home. This group will consist of progressive resistance exercises for the upper and lower extremity with a portable training device, a motor control-based program of gait/balance training, Activities of Daily Living (ADL) training, and mobility training. Receives: Behavioral: Progressive Multi-Component Intervention |
| Usual Care Group | Active comparator | The patients in this group will receive approximately five visits of "usual home care" but the total number of visits will be determined by the therapist as part of usual care. These visits will likely occur at 1-2 times per week for 3-4 weeks. This group will receive intervention as determined by the physical therapist's initial examination. Interventions may include patient education, home exercises, low intensity strengthening exercise, training in gait, balance and transfers; home safety and assistive device assessment. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
Time it takes to walk a 4 meter path, key to independent functioning
Measured: 60 days
Secondary outcomes (2)
Modified Physical Performance Test (mPPT)
Assesses 7 different tasks. Based on the time taken to complete the tasks, a score from 0 (unable to complete) to 4 (performed quickly and easily) if given for each task. A maximal score of 28 is given, including tasks that involved the upper and lower extremity function.
Measured: 60 days
Late-Life Function and Disability Instrument (LLFDI)
Evaluates limitation and frequency of taking part in 16 major life tasks in its disability component, and 32 functional tasks in its functional component, of which 14 tasks comprise basic lower extremity function.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJun 2011
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Older AdultsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Arcadia University
- Responsible party
- Sponsor
- Investigators
- Jennifer E Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado, DenverKate Mangione, PT, PhD, Principal investigator, Arcadia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872637
- Sponsor's protocol ID
- 10-0432
- Other IDs
- Innovator's Fund, APTA
- Status last verified
- May 2017
- First submitted
- 4 Jun 2013
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Activity, Participation And Function After Acute Hospitalization In Older Adults With Multiple Chronic Conditions: Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01872637
- Acronym / sponsor ID
- 10-0432
- Conditions
- Frail Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Arcadia University
- Study start
- Jun 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Jun 2013 (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.
Hospitalization increases the risk for new disability in older adults. In the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. The proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. If successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.
Detailed description
Background: Hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. No studies have examined the effectiveness of Home Health (HH) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. Our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. This intervention is designed to work within the existing Medicare system and has potential for immediate clinical impact.
Purpose: The primary aim of our study is to determine if a progressive multi-component (PMC) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (UC) physical therapy. We hypothesize that there will be a greater improvement in gait speed measured for the PMC group compared to the UC group following one episode of care. Benefits of PMC will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint).
Design: We propose to conduct a single blind randomized two arm clinical trial (RCT) in older adults discharged from acute care and referred to HH physical therapy. Both interventions (PMC \& UC) will be Medicare-reimbursed. All assessments and interventions will occur in the patients' homes.
Methods: Twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Multi-Component Intervention | Experimental | Behavioral: Progressive Multi-Component InterventionPatients in this exercise group will receive 10-18, 45-60 minute, physical therapy visits in their home. This group will consist of progressive resistance exercises for the upper and lower extremity with a portable training device, a motor control-based program of gait/balance training, Activities of Daily Living (ADL) training, and mobility training. |
| Usual Care Group | Active comparator | Behavioral: Usual CareThe patients in this group will receive approximately five visits of "usual home care" but the total number of visits will be determined by the therapist as part of usual care. These visits will likely occur at 1-2 times per week for 3-4 weeks. This group will receive intervention as determined by the physical therapist's initial examination. Interventions may include patient education, home exercises, low intensity strengthening exercise, training in gait, balance and transfers; home safety and assistive device assessment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 years or older
- referred to home care physical therapy
- have at least 3 comorbid conditions
- ambulatory without human assistance prior to hospitalization
Key exclusion criteria (8 listed)
- acute lower extremity fractures with weight-bearing restriction
- elective joint replacement surgery
- active cancer diagnosis
- acute cardiac surgery
- lower extremity amputation
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 |
|---|---|---|
| Progressive Multi-Component Intervention | Behavioural | Progressive Multi-Component Intervention |
| Usual Care | Behavioural | Usual Care Group |
Primary outcome
Gait Speed
Time frame: 60 days
Time it takes to walk a 4 meter path, key to independent functioning
2 secondary outcomes
Modified Physical Performance Test (mPPT)
Time frame: 60 days
Late-Life Function and Disability Instrument (LLFDI)
Time frame: 60 days
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 17 May 2017.
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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.
Jennifer E Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
Kate Mangione, PT, PhD principal investigator
Arcadia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Multi-Component Intervention in people with Frail Older Adults, run by University of Colorado, Denver at 2 sites 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 8 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Gait Speed (time frame: 60 days). 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 17 May 2017.