Arthroplasty, Replacement, KneePhase 1/2NCT01799772
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA
A Phase 1/2 study testing Comprehensive Behavioral Intervention in people with Arthroplasty, Replacement, Knee, run by University of Pittsburgh at 1 site in United States.
Trial summary
Patients who undergo a replacement of their knees are generally older adults who have dealt with severe knee pain and joint degeneration for a long time. The majority of them are sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and helps patients to live a better life. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Comprehensive Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2013
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral TKA at least three months prior to, but no longer than six months prior to study participation;
- Surgical technique was a minimally invasive (quadriceps sparing) TKA performed by the same experienced surgeon;
- Provide a written medical clearance to participate in the study;
- Speak fluent English;
- Are older than 50 years.
Who cannot join
- Have bilateral or TKA revision;
- Have hip or ankle joint replacement;
- Are unable to comfortably bear weight on the surgical knee;
- Had 2 or more falls within past year;
- Have uncontrolled medical condition that would prevent safe participation in the study (uncontrolled blood pressure, dyspnea at rest, cardiovascular disease, absolute contraindications to exercise, and diabetes);
- Participating in regular exercise during prior 6 months;
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- Use beta blockers,
- Have a neurological condition that affects locomotion;
- Have had a malignancy, life-threatening illness or surgery in the past six months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: The Feasibility of a Comprehensive Behavioral Intervention in Patient Post Total Knee Arthroplasty
Patients who undergo a replacement of their knees are generally older adults who have dealt with severe knee pain and joint degeneration for a long time. The majority of them are sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and helps patients to live a better life. However, after the surgery, some patients have difficulty performing basic activities such as walking, or going up-down stairs, and the majority remains sedentary and gain weight. These combined problems leave patients at risk of worsening their health. Therefore, a treatment that takes care of all these combined problems is needed. We propose an all-inclusive treatment, called comprehensive behavioral intervention (CBI) that intends to improve the long-term effects of exercise programs. The CBI combines exercise program with promotion of physical activity, orientation on healthy nutrition, and an education approach that promotes self-initiative towards healthy habits. The overall aim of this proposed study is to test how patients post TKA will like the CBI program, how safe the program is, and adapt the program as needed for better acceptability. We believe the CBI will be safe, well tolerated, and will improve the ability of patients to perform physical tasks. We also believe the program will increase the amount of physical activity, will promote maintenance of healthy weight, and will help the patients to obtain and maintain healthy habits. In this study subjects will be selected by a flip of a coin to receive either our CBI program or a more traditional exercise program. Subjects will be tested before and after the treatments. Our measures of main interest are how well subjects move around and how physically active they are. We are also interested on the effect of the interventions on body weight, blood pressure, eating habits, and general health. The team of researchers for this study includes several disciplines. The proposed study will defend the need for a larger study that can have a very important impact on the public health of patients post TKA. The reason for the public health impact is if the physical limitations experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by increasing physical activity and promoting healthy weight, it may improve general health and prevent chronic diseases. Last, developing educational intervention that promotes self-initiative will result in long-term health benefits post TKA.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Comprehensive Behavioral Intervention, Standard of Care Exercise Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Behavioral InterventionBehavioural
- Evidence-based exercise program - Combination of high intensity lower extremity strengthening, endurance on the treadmill, functional task-oriented exercises, and balance techniques. During 12 sessions, subjects will be instructed to become independent in performing the exercises at home.
- Physical activity promotion - Instructions to engage in moderate intensity exercise 5 days/week will be delivered along with the exercise program.
- Healthy nutrition guidance - Instructions on healthy nutrition delivered by a dietitian.
- Self-management - Basic self-management skills advocated by the Arthritis Foundation Self-Help Program and behavioral strategies (self-monitoring, problem solving, relapse prevention, and goal-setting) and feedback into approaches a, b and c.
Standard of Care Exercise ProgramOther
Typical rehabilitation after TKA surgery
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive behavioral intervention | Experimental | It will involve regular contacts over 6 month period. It will include 2 weekly contacts for weeks 1-6, weekly contacts for weeks 7-8, bi-weekly contact for months 3-4, and monthly contact for months 5-6. There is a combination of 20 individual and group-based sessions.
It is a combination of 4 components: a) Evidence-based exercise program, b) Physical activity promotion, c) Healthy nutrition guidance, and d) Self-management. Receives: Behavioral: Comprehensive Behavioral Intervention |
| Standard of Care Exercise Program (SCE) | Active comparator | The SCE will be delivered by a physical therapist. It represents the typical rehabilitation after TKA surgery. It is expected to provide small and short-lived functional improvement. Subjects will participate in 12 supervised sessions (2 x/week, for 6 weeks). The SCE consists of: a) lower extremity range of motion and stretching exercises, b) lower extremity strengthening exercises of moderate intensity, and d) endurance exercises using treadmill. Receives: Other: Standard of Care Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-reported physical function
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index - Physical Function scale (WOMAC-PF) at 6 months.
Measured: 6 months
Secondary outcomes (5)
Change from Baseline in Performance-based physical function
Change from Baseline in Self-selected gait speed at 6 months.
Measured: 6 months
Change from Baseline in Performance-based Physical Function
Change from Baseline in Timed 5 chair rise at 6 months.
Measured: 6 months
Change from Baseline in Performance-based Physical Function
Change from Baseline in single leg balance time at 6 months.
Measured: 6 months
Change from Baseline in Performance-based Physical Function
Change from Baseline in timed ascend/descend stair test at 6 months.
Measured: 6 months
Change from Baseline in Performance-based Physical Test
Change from Baseline in 6 minutes walk test at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionAug 2013
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 Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara R Piva, PT, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799772
- Sponsor's protocol ID
- PRO11030404
- Status last verified
- Sep 2014
- First submitted
- 8 Feb 2013
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Piva SR, Almeida GJ, Gil AB, DiGioia AM, Helsel DL, Sowa GA. Effect of Comprehensive Behavioral and Exercise Intervention on Physical Function and Activity Participation After Total Knee Replacement: A Pilot Randomized Study. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1855-1862. doi: 10.1002/acr.23227. Epub 2017 Nov 2.
PubMed 28217891
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Comprehensive Behavioral Intervention in Patient Post Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01799772
- Acronym / sponsor ID
- PRO11030404
- Conditions
- Arthroplasty, Replacement, Knee
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Feb 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.
Patients who undergo a replacement of their knees are generally older adults who have dealt with severe knee pain and joint degeneration for a long time. The majority of them are sedentary, and around 1/3 are obese. The knee replacement surgery decreases knee pain and helps patients to live a better life. However, after the surgery, some patients have difficulty performing basic activities such as walking, or going up-down stairs, and the majority remains sedentary and gain weight. These combined problems leave patients at risk of worsening their health. Therefore, a treatment that takes care of all these combined problems is needed. We propose an all-inclusive treatment, called comprehensive behavioral intervention (CBI) that intends to improve the long-term effects of exercise programs. The CBI combines exercise program with promotion of physical activity, orientation on healthy nutrition, and an education approach that promotes self-initiative towards healthy habits. The overall aim of this proposed study is to test how patients post TKA will like the CBI program, how safe the program is, and adapt the program as needed for better acceptability. We believe the CBI will be safe, well tolerated, and will improve the ability of patients to perform physical tasks. We also believe the program will increase the amount of physical activity, will promote maintenance of healthy weight, and will help the patients to obtain and maintain healthy habits. In this study subjects will be selected by a flip of a coin to receive either our CBI program or a more traditional exercise program. Subjects will be tested before and after the treatments. Our measures of main interest are how well subjects move around and how physically active they are. We are also interested on the effect of the interventions on body weight, blood pressure, eating habits, and general health. The team of researchers for this study includes several disciplines. The proposed study will defend the need for a larger study that can have a very important impact on the public health of patients post TKA. The reason for the public health impact is if the physical limitations experiences by patients post TKA are left untreated, they tend to get worse. Furthermore, by increasing physical activity and promoting healthy weight, it may improve general health and prevent chronic diseases. Last, developing educational intervention that promotes self-initiative will result in long-term health benefits post TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive behavioral intervention | Experimental | Behavioral: Comprehensive Behavioral InterventionIt will involve regular contacts over 6 month period. It will include 2 weekly contacts for weeks 1-6, weekly contacts for weeks 7-8, bi-weekly contact for months 3-4, and monthly contact for months 5-6. There is a combination of 20 individual and group-based sessions. It is a combination of 4 components: a) Evidence-based exercise program, b) Physical activity promotion, c) Healthy nutrition guidance, and d) Self-management. |
| Standard of Care Exercise Program (SCE) | Active comparator | Other: Standard of Care Exercise ProgramThe SCE will be delivered by a physical therapist. It represents the typical rehabilitation after TKA surgery. It is expected to provide small and short-lived functional improvement. Subjects will participate in 12 supervised sessions (2 x/week, for 6 weeks). The SCE consists of: a) lower extremity range of motion and stretching exercises, b) lower extremity strengthening exercises of moderate intensity, and d) endurance exercises using treadmill. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral TKA at least three months prior to, but no longer than six months prior to study participation;
- Surgical technique was a minimally invasive (quadriceps sparing) TKA performed by the same experienced surgeon;
- Provide a written medical clearance to participate in the study;
- Speak fluent English;
- Are older than 50 years.
Key exclusion criteria (9 listed)
- Have bilateral or TKA revision;
- Have hip or ankle joint replacement;
- Are unable to comfortably bear weight on the surgical knee;
- Had 2 or more falls within past year;
- Have uncontrolled medical condition that would prevent safe participation in the study (uncontrolled blood pressure, dyspnea at rest, cardiovascular disease, absolute contraindications to exercise, and diabetes);
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 |
|---|---|---|
| Comprehensive Behavioral Intervention1. Evidence-based exercise program - Combination of high intensity lower extremity strengthening, endurance on the treadmill, functional task-oriented exercises, and balance techniques. During 12 sessions, subjects will be instructed to become independent in performing the exercises at home. 2. Physical activity promotion - Instructions to engage in moderate intensity exercise 5 days/week will be delivered along with the exercise program. 3. Healthy nutrition guidance - Instructions on healthy nutrition delivered by a dietitian. 4. Self-management - Basic self-management skills advocated by the Arthritis Foundation Self-Help Program and behavioral strategies (self-monitoring, problem solving, relapse prevention, and goal-setting) and feedback into approaches a, b and c. | Behavioural | Comprehensive behavioral intervention |
| Standard of Care Exercise ProgramTypical rehabilitation after TKA surgery | Other | Standard of Care Exercise Program (SCE) |
Primary outcome
Change from Baseline in Self-reported physical function
Time frame: 6 months
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index - Physical Function scale (WOMAC-PF) at 6 months.
5 secondary outcomes
Change from Baseline in Performance-based physical function
Time frame: 6 months
Change from Baseline in Performance-based Physical Function
Time frame: 6 months
Change from Baseline in Performance-based Physical Function
Time frame: 6 months
Change from Baseline in Performance-based Physical Function
Time frame: 6 months
Change from Baseline in Performance-based Physical Test
Time frame: 6 months
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 10 Sep 2014.
- Derived from this study: PubMed 28217891Piva SR, Almeida GJ, Gil AB, DiGioia AM, Helsel DL, Sowa GA. Effect of Comprehensive Behavioral and Exercise Intervention on Physical Function and Activity Participation After Total Knee Replacement: A Pilot Randomized Study. Arthritis Care Res (Hoboken). 2017 Dec;69(12):1855-1862. doi: 10.1002/acr.23227. Epub 2017 Nov 2.
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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.
Sara R Piva, PT, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Comprehensive Behavioral Intervention in people with Arthroplasty, Replacement, Knee, run by University of Pittsburgh 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 5 inclusion and 9 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 10 Sep 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in Self-reported physical function (time frame: 6 months). 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 NCT01799772, 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 10 Sep 2014.