Physical ActivityNCT02724137
A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study
A study testing Fitbit® and Physical Therapy Rehab in people with Physical Activity, run by University of Delaware at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Determine whether the Physical Therapy (PT) \& Fitbit® intervention should proceed to a full-scale clinical trial. This decision will be based on three hypotheses: Treatment promise (Hypothesis 1A): People in the PT \& Fitbit® will walk 1250 more steps/day and spend 7 min/day more… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Fitbit® and Physical Therapy Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Nov 2018
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 45
- Seeking outpatient physical therapy after unilateral TKR
Who cannot join
- Not interested in increasing physical activity
- Co-morbidities other than unilateral TKR that limit physical activity
- Planning on having another lower extremity surgery in the next 6 months
- Have had another lower extremity surgery in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
- Determine whether the Physical Therapy (PT) \& Fitbit® intervention should proceed to a full-scale clinical trial. This decision will be based on three hypotheses: Treatment promise (Hypothesis 1A): People in the PT \& Fitbit® will walk 1250 more steps/day and spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): < 5% will have adverse events because of the intervention, A research assistant will collect data on adverse events that occur from the time of randomization until the last follow-up visit 3 months after discharge from PT. An adverse event is any unfavorable or unintended diagnosis, sign, symptom, or disease temporarily associated with the study intervention, which may or may not be related to the intervention. Adverse events include any new events not present during the pre-intervention period or events that were present during the pre-intervention period which have increased in severity. Major adverse events, such as infection, re-hospitalization or development of new comorbidities will also be noted. Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit at 6 months and 12 months.
- To evaluate the short- and long-term adherence of the PT \& Fitbit® intervention. Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT\& Fitbit® group will wear the Fitbit® and participate in goal setting and behavioral counseling while in PT. Long-term Adherence (Hypothesis 2B): 75% of PT \& Fitbit® will wear the Fitbit® at 6 months and 12 months.
- To quantify changes in potential underlying mechanisms for increased physical activity. (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and participation in daily activities will be associated with improvements in physical activity.
- To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical record, the treating PT will check off that they 1) reviewed physical activity recorded by the Fitbit® and 2) discussed step goals for all study subjects randomized to the intervention group. (4b) treating PTs will be asked to audio record five-intervention interactions/week using a digital audio recorder. A research assistant will then assess whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the duration of the intervention will be noted.
Read the detailed description
The study is a pilot study to determine the feasibility of a full trial.
- Conditions
- Physical Activity
- Being tested
- Fitbit®, Physical Therapy Rehab
- Keywords
- Total Knee Replacement, Physical Therapy, Fitbit®
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit®Behavioural
Participants can read how many steps/day they walked on the Fitbit® daily. The treating physical therapist reviews Fitbit® recorded steps from the previous week and together with the patient sets a new step goal. The physical therapist discusses barriers to meeting step goals are discussed. Self-reward for meeting step/goal is set weekly. Participants in this group will also receive 1-month phone calls for 6-months after completing physical therapy rehabilitation to discuss physical activity, set monthly step count goal, barriers to overcoming goal and to continue to develop a reward system for when the participant achieves their step count goal.
Physical Therapy RehabOther
Standard of care physical therapy after total knee replacement. The goals of physical therapy are to increase knee range of motion and strength, improve balance and agility, and increase daily walking. Physical therapy appointment times range from 45-60 minutes with appointments occurring 2 times a week for 6-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Rehab and Fitbit® | Experimental | Standard outpatient physical therapy rehabilitation after total knee replacement with the addition of a Fitbit® to promote physical activity. Receives: Behavioral: Fitbit®; Other: Physical Therapy Rehab |
| Physical Therapy Rehab | Active comparator | Standard outpatient physical therapy rehabilitation after total knee replacement. Receives: Other: Physical Therapy Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity measured by the Actigraph GT3X monitor
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. Also at 6-months and 12-months from discharge from physical therapy rehab.
Secondary outcomes (9)
Short term adherence to treatment as measured by physical therapist.
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Self report long-term adherence to treatment as measured by research assistant.
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: 6 months after discharge from physical therapy rehab
Reporting of adverse events
This time frame is open-ended by design. The goal is to model our trial off of current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Number participants excluded from study as measured by research assistant.
Number of participants that do not meet inclusion criteria.
Measured: At initial physical therapy evaluation.
Reason why the participant was excluded from the study.
Categories: 1) no time/too busy 2) too much trouble 3) illness (self) 4) illness family 5) not interested 6) concerned about injury/pain 7) concerned about quality of care 8) refused
Measured: At initial physical therapy evaluation.
Self reported kinesiophobia using the Tampa-15 Scale for Kinesiophobia.
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Self reported self-efficacy using the Self-Efficacy Scale for Exercise.
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Intervention Fidelity using electronic medical records and digital audio recordings.
The goal is to investigate how consistent the physical activity intervention is provided to the patients. Consistency will be measured using two methods. The first is to use the EMR to check if current steps/day were recorded by the treating PT. The second is to use the digital audio recording in a subset of patients to evaluate if steps/day from the past week were reviewed by the treating PT, and if a step goal was discussed for the next week. This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: During outpatient physical therapy rehab which is expected to be 8 weeks.
Self reported pain catastrophizing using the Pain Catastrophizing Scale (PSC)
This time frame is open-ended by design. Our goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
Measured: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel K. White, University of Delaware
- Investigators
- Daniel K White, PT, ScD, MSc, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724137
- Sponsor's protocol ID
- 643239-10
- Status last verified
- Nov 2018
- First submitted
- 23 Feb 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Pilot Study
- ClinicalTrials.gov ID
- NCT02724137
- Acronym / sponsor ID
- 643239-10
- Conditions
- Physical Activity
- Keywords
- Total Knee Replacement, Physical Therapy, Fitbit®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 31 Mar 2016 (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.
The purpose of this study is to:
- Determine whether the Physical Therapy (PT) \& Fitbit® intervention should proceed to a full-scale clinical trial. This decision will be based on three hypotheses: Treatment promise (Hypothesis 1A): People in the PT \& Fitbit® will walk 1250 more steps/day and spend 7 min/day more in moderate to vigorous physical activity (MVPA) than the control at discharge and at 6 months and 12 months, Safety (Hypothesis 1B): < 5% will have adverse events because of the intervention, A research assistant will collect data on adverse events that occur from the time of randomization until the last follow-up visit 3 months after discharge from PT. An adverse event is any unfavorable or unintended diagnosis, sign, symptom, or disease temporarily associated with the study intervention, which may or may not be related to the intervention. Adverse events include any new events not present during the pre-intervention period or events that were present during the pre-intervention period which have increased in severity. Major adverse events, such as infection, re-hospitalization or development of new comorbidities will also be noted. Recruitment (Hypothesis 1C): 75 recruited, 90% to complete trial, and 85% complete visit at 6 months and 12 months.
- To evaluate the short- and long-term adherence of the PT \& Fitbit® intervention. Short-term Adherence (Hypothesis 2A): 90% of subjects in the PT\& Fitbit® group will wear the Fitbit® and participate in goal setting and behavioral counseling while in PT. Long-term Adherence (Hypothesis 2B): 75% of PT \& Fitbit® will wear the Fitbit® at 6 months and 12 months.
- To quantify changes in potential underlying mechanisms for increased physical activity. (Hypothesis 3): Change in self-efficacy for physical activity, walking endurance and participation in daily activities will be associated with improvements in physical activity.
- To assess intervention fidelity (Hypothesis 4): (4a) using the electronic medical record, the treating PT will check off that they 1) reviewed physical activity recorded by the Fitbit® and 2) discussed step goals for all study subjects randomized to the intervention group. (4b) treating PTs will be asked to audio record five-intervention interactions/week using a digital audio recorder. A research assistant will then assess whether the PT 1) reviewed physical activity and 2) discussed step goals. Lastly, the duration of the intervention will be noted.
Detailed description
The study is a pilot study to determine the feasibility of a full trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Rehab and Fitbit® | Experimental | Behavioral: Fitbit®, Other: Physical Therapy RehabStandard outpatient physical therapy rehabilitation after total knee replacement with the addition of a Fitbit® to promote physical activity. |
| Physical Therapy Rehab | Active comparator | Other: Physical Therapy RehabStandard outpatient physical therapy rehabilitation after total knee replacement. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over the age of 45
- Seeking outpatient physical therapy after unilateral TKR
Key exclusion criteria (4 listed)
- Not interested in increasing physical activity
- Co-morbidities other than unilateral TKR that limit physical activity
- Planning on having another lower extremity surgery in the next 6 months
- Have had another lower extremity surgery in the past 6 months
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 |
|---|---|---|
| Fitbit®Participants can read how many steps/day they walked on the Fitbit® daily. The treating physical therapist reviews Fitbit® recorded steps from the previous week and together with the patient sets a new step goal. The physical therapist discusses barriers to meeting step goals are discussed. Self-reward for meeting step/goal is set weekly. Participants in this group will also receive 1-month phone calls for 6-months after completing physical therapy rehabilitation to discuss physical activity, set monthly step count goal, barriers to overcoming goal and to continue to develop a reward system for when the participant achieves their step count goal. | Behavioural | Physical Therapy Rehab and Fitbit® |
| Physical Therapy RehabStandard of care physical therapy after total knee replacement. The goals of physical therapy are to increase knee range of motion and strength, improve balance and agility, and increase daily walking. Physical therapy appointment times range from 45-60 minutes with appointments occurring 2 times a week for 6-8 weeks. | Other | Physical Therapy Rehab, Physical Therapy Rehab and Fitbit® |
Primary outcome
Physical activity measured by the Actigraph GT3X monitor
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. Also at 6-months and 12-months from discharge from physical therapy rehab.
This time frame is open-ended by design. The goal is to model current physical therapy practice, in which a patient after total knee replacement goes to outpatient physical therapy and receives physical therapy services based on a timeframe planned out by their treating physical therapist. Treatment is then discontinued based on the patient's clinical presentation (ie functional mobility, strength gains, range of motion gains, patient specific goals, etc).
9 secondary outcomes
Short term adherence to treatment as measured by physical therapist.
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Self report long-term adherence to treatment as measured by research assistant.
Time frame: 6 months after discharge from physical therapy rehab
Reporting of adverse events
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Number participants excluded from study as measured by research assistant.
Time frame: At initial physical therapy evaluation.
Reason why the participant was excluded from the study.
Time frame: At initial physical therapy evaluation.
Self reported kinesiophobia using the Tampa-15 Scale for Kinesiophobia.
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Self reported self-efficacy using the Self-Efficacy Scale for Exercise.
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
Intervention Fidelity using electronic medical records and digital audio recordings.
Time frame: During outpatient physical therapy rehab which is expected to be 8 weeks.
Self reported pain catastrophizing using the Pain Catastrophizing Scale (PSC)
Time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks.
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 20 Nov 2018.
- Individual participant dataSharing planned: Yes
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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.
Daniel K White, PT, ScD, MSc principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit® and Physical Therapy Rehab in people with Physical Activity, run by University of Delaware 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 4 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 20 Nov 2018. 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?
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?
Physical activity measured by the Actigraph GT3X monitor (time frame: Initial physical therapy evaluation to discharge from outpatient physical therapy rehab which is expected to be 8 weeks. Also at 6-months and 12-months from discharge from physical therapy rehab.). 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 20 Nov 2018.