Knee OsteoarthritisPEAKNCT04980300

Delaware Physical Exercise and Activity for Knee Osteoarthritis

A study testing Intervention in people with Knee Osteoarthritis, run by University of Delaware at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 1 siteUnited States
Study dates: 3 Jul 2021to 1 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:
being at least 45 years of age;
having activity-related joint pain;
having morning stiffness ≤ 30 minutes;
have a history of knee pain for at least 12 weeks;
are interested in becoming more physically active;

Show all 11Show fewer

have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and
are able to commit to the study for 12 weeks and willing to wear physical activity monitors
live in the contiguous United States
comfortable participating in a program delivered in English
is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire.

Who cannot join

regularly exercise more than 60 minutes/week; or
has a scheduled knee or hip joint replacement; or
has had physical therapy for knee OA in the past 6 months; or
participated in a strength training program for the lower extremities in the past 6 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Delaware
Newark, Delaware, 19713

Other trials in United States

About this study

Official title: Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)

The objective of this project is to examine the efficacy of an innovative Telehealth Physical Therapy (PT) program for adults with knee osteoarthritis (OA) to increase physical activity over 12 weeks in adults with knee OA compared to a control group receiving web-based resources about knee OA. One hundred individuals with knee osteoarthritis (OA), who are over the age of 45, and are also looking to move more, will be randomized into a brief or expanded intervention group. The control includes an online, guided video orientation from a physical therapist to web resources for strengthening exercises, physical activity, and pain management strategies for knee OA. The intervention includes up to 5 online consultations with a physical therapist over a 12-week period who will prescribe strengthening exercises, physical activity goals, and pain management strategies for knee OA.

Read the detailed description

Delaware PEAK (Physical therapy Exercise and Activity for Knee osteoarthritis) is a delivered remotely by a physical therapist over 5 one-on-one video conference (Zoom Platform) consultations lasting 45 to 60 minutes each over 12 weeks. Each consultation focuses on strengthening exercises, physical activity goals, and education to debunk common OA-related myths and misconceptions. Delaware PEAK utilizes a well-established behavioral counseling method, Motivational Interviewing, to increase self-efficacy (confidence) related to exercise, while delivering all aspects of the intervention.

The objective of this project is to examine the efficacy of Delaware PEAK to increase physical activity in adults with knee OA compared to a control group receiving web-based resources about knee OA and exercise. The rationale for our study is that there is a need to examine whether PEAK can directly target the mismatch between OA recommendations and practice patterns. Our central hypothesis is that Delaware PEAK will increase physical activity and will increase the belief that exercise is helpful and not harmful, compared with a control group receiving web-based OA treatment resources. Successful completion of this proposal will provide the evidence necessary to scale up this low-cost intervention, with the goal of increasing the number of adults who use exercise to manage their knee OA and thus reducing the burden of disease.

The primary endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase MVPA over 12 weeks compared to a control group receiving web-based resources about knee OA and exercise.

The secondary analyses endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase health beliefs in Physical Exercise and Physical Therapy, light physical activity (LPA), and steps per day, over 24 weeks compared to a control group receiving web-based resources about knee OA and exercise. We also will assess change in MVPA over 24 weeks.

Our exploratory endpoints include change in pain, symptoms, function in activities of daily living, function in sport and recreation, and quality of life over 12 weeks and 24 weeks. We will also examine change in treatment expectations before and after randomization. Lastly, we will examine change in treatment adherence from 12 to 24 weeks among those in the expanded intervention group.

Conditions: Knee Osteoarthritis
Being tested: Intervention, Control
Keywords: Physical Activity, Physical Therapy, Telehealth, Strengthening Exercise
Medical subject headings: Osteoarthritis, Knee, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InterventionBehavioural
Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
ControlBehavioural
Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.

Study groups in NCT04980300
Study group	Role	What they receive
Intervention	Experimental	Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Receives: Behavioral: Intervention
Control	Active comparator	Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Moderate-to-vigorous Intensity Physical Activity
Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided.
Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA
Measured: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome

Secondary outcomes (6)

Change in Treatment Beliefs of Physical Therapy: Positive
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.
Scores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Measured: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Exercise: Positive
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.
Scores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Measured: Baseline, 12 weeks, and 24 weeks
Change in Light Intensity Physical Activity (LPA)
Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes).
Measured: Baseline, 12 weeks, and 24 weeks
Change in Steps/Day
Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for > 4 days.
Measured: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Therapy: Negative
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy.
Scores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs
Measured: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Exercise: Negative
Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity.
Scores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs
Measured: Baseline, 12 weeks, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 20211 Jun 2023

First posted28 Jul 2021
Study start3 Jul 2021
Primary completion1 Jun 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies 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: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04980300
Sponsor's protocol ID: 1730922
Acronym: PEAK
Status last verified: Apr 2024
First submitted: 17 Jul 2021
Last updated: 1 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

White DK, Hinman RS, Liles S, Bye TV, Voinier D, Copson J, Schmitt LA, Bodt BA, Jakiela JT. A Telehealth Physical Therapy Intervention to Increase Physical Activity in Adults With Knee OA: The Delaware PEAK Randomized Controlled Trial. J Orthop Sports Phys Ther. 2025 May;55(5):377-385. doi: 10.2519/jospt.2025.13132.
PubMed 40258072
Aily JB, Copson J, Voinier D, Jakiela J, Hinman R, Grosch M, Noonan C, Armellini M, Schmitt L, White M, White D. Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study. J Med Internet Res. 2023 May 18;25:e41358. doi: 10.2196/41358.
PubMed 37200067
Jakiela JT, Voinier D, Hinman RS, Copson J, Schmitt LA, Leonard TR, Aily JB, Bodt BA, White DK. Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Phys Ther. 2023 Feb 1;103(2):pzac139. doi: 10.1093/ptj/pzac139.
PubMed 36200390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)
ClinicalTrials.gov ID: NCT04980300
Acronym / sponsor ID: PEAK / 1730922
Conditions: Knee Osteoarthritis
Keywords: Physical Activity, Physical Therapy, Telehealth, Strengthening Exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: University of DelawareUniversity, hospital or other
Study start: 3 Jul 2021 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 28 Jul 2021 (actual)
Results: Posted 1 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: InterventionVirtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.
Control	Active comparator	Behavioral: ControlWeb-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:
have a history of knee pain for at least 12 weeks;
are interested in becoming more physically active;
have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and
are able to commit to the study for 12 weeks and willing to wear physical activity monitors

Key exclusion criteria (4 listed)

regularly exercise more than 60 minutes/week; or
has a scheduled knee or hip joint replacement; or
has had physical therapy for knee OA in the past 6 months; or
participated in a strength training program for the lower extremities 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
InterventionParticipants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.	Behavioural	Intervention
ControlParticipants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.	Behavioural	Control

Primary outcome

Change in Moderate-to-vigorous Intensity Physical Activity
Time frame: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome
Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA

6 secondary outcomes

Change in Treatment Beliefs of Physical Therapy: Positive
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Exercise: Positive
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Light Intensity Physical Activity (LPA)
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Steps/Day
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Therapy: Negative
Time frame: Baseline, 12 weeks, and 24 weeks
Change in Treatment Beliefs of Physical Exercise: Negative
Time frame: Baseline, 12 weeks, and 24 weeks

Results and safety

Results posted to the registry on 1 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Expanded Intervention	51	45
Brief Intervention	52	51

Primary outcome: Change in Moderate-to-vigorous Intensity Physical Activity

Time frame: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome. Mean (95% Confidence Interval). Unit: min/day of MVPA

Measure	Intervention n = 41	Control n = 47
12 weeks - Baseline	0.7 (-4.8 to 6.2)	2.6 (-2.6 to 7.7)
24 weeks - Baseline	2.7 (-2.9 to 8.2)	1.6 (-3.6 to 6.8)

Population analysed: For activity monitor data, we used a modified intention-to-treat method, i.e., all randomly assigned participants who wore the monitor for \> 4 days for at least 10 hours/day at baseline were included in analyses. There were 15 (14.6%) study participants who were randomized, but did not have valid baseline activity monitor data despite wearing the monitor and were excluded from the primary analysis. Thus, the modified intention-to-treat sample included n=88.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from study enrollment until study completion at the 24 week follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Expanded Intervention	0 of 51 (0%)	44 of 51 (86.3%)	0 of 51
Brief Intervention	3 of 52 (5.8%)	10 of 52 (19.2%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40258072White DK, Hinman RS, Liles S, Bye TV, Voinier D, Copson J, Schmitt LA, Bodt BA, Jakiela JT. A Telehealth Physical Therapy Intervention to Increase Physical Activity in Adults With Knee OA: The Delaware PEAK Randomized Controlled Trial. J Orthop Sports Phys Ther. 2025 May;55(5):377-385. doi: 10.2519/jospt.2025.13132.
Derived from this study: PubMed 37200067Aily JB, Copson J, Voinier D, Jakiela J, Hinman R, Grosch M, Noonan C, Armellini M, Schmitt L, White M, White D. Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study. J Med Internet Res. 2023 May 18;25:e41358. doi: 10.2196/41358.
Derived from this study: PubMed 36200390Jakiela JT, Voinier D, Hinman RS, Copson J, Schmitt LA, Leonard TR, Aily JB, Bodt BA, White DK. Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Phys Ther. 2023 Feb 1;103(2):pzac139. doi: 10.1093/ptj/pzac139.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Knee Osteoarthritis, 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 11 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 1 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 1 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Moderate-to-vigorous Intensity Physical Activity (time frame: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome). 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 NCT04980300, which also lists 3 linked publications.

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 1 Jan 2025.