OsteoarthritisAIMNCT01192516
Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
A study testing Tailored Activity Pacing and General Activity Pacing in people with Osteoarthritis and Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Tailored Activity Pacing and General Activity Pacing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 50 years and older
- Reported pain for at least 3 months
- Mild-moderate pain severity according to the WOMAC pain scale
- Radiographic evidence of knee or hip osteoarthritis (Kellgren-Lawrence score of 2 in at least one joint)
- Community-dwelling (i.e. own home, apartment, senior residence)
- Ambulatory with or without a cane or walker
Show all 9Show fewer
- Adequate cognition to complete study activities (score of 5 on the 6-Item Screener)
- Ability to use the Actiwatch-S (Phillips-Respironics, Mini-Mitter, Bend OR)accelerometer to record symptoms and activity patterns (ascertained by completion of a learning module specific to the use of the device in this study)
- English-speaking
Who cannot join
- Self-reported medical history of conditions with pain and/or fatigue as a known and marked symptom (e.g multiple sclerosis, rheumatoid arthritis)
- Medically unstable (e.g. acute conditions or acute presentations of chronic conditions)
- Anemia (hemoglobin of <10 for men and <11 for women)
- Unmanaged thyroid dysfunction (Thyroid stimulating hormone <.035>5.5 mg/dl)
- 2 or more days of complete bed rest within the last month
- Limb hemiplegia or amputation
Show all 13Show fewer
- Arthroscopic procedure within the previous 2 months
- Joint injection within the previous 3 months
- Total or partial joint replacement within the previous 6 months
- Self-reported illness or conditions that impair cooperation with the study team or ability to complete study procedures
- Current enrollee in physical or occupational therapy for symptoms associated with osteoarthritis
- Current attendance or attendance within the previous year in a cognitive behavioral therapy program or other self-management program that includes activity pacing instruction
- Any other unforeseen exclusion criteria that, by the opinion of the study personnel, would make the participant unable to safely or effectively complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
About this study
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. A secondary objective is to evaluate the natural history of symptoms and physical disability over time among people with knee and hip osteoarthritis.
Read the detailed description
In the United States, osteoarthritis is a growing public health issue and a leading cause of disability among older adults. Almost 50% of users of the Veterans Affairs (VA) system present with osteoarthritis. Veterans are a particularly important group to target for symptom management interventions as they are twice as likely as non-veterans to report chronic joint symptoms and activity limitations. There are few evidence-based symptom management interventions offered by health care professionals, such as occupational and physical therapists, at the time when people are seeking treatment for their symptoms. The proposed activity pacing intervention is individually-tailored to a person's symptom and activity patterns. This tailoring provides a personally-relevant and focused intervention that may help people adopt this strategy into their daily lives.
- Conditions
- Osteoarthritis, Pain
- Being tested
- Tailored Activity Pacing, General Activity Pacing
- Keywords
- Osteoarthritis, Activity Pacing
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Activity PacingBehavioural
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
General Activity PacingBehavioural
Therapeutic intervention using generalized pacing instruction to manage symptoms
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Tailored activity pacing Receives: Behavioral: Tailored Activity Pacing |
| Arm 2 | Experimental | General activity pacing and symptom management (Occupational therapy) Receives: Behavioral: General Activity Pacing |
| Arm 3 | No intervention | Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue- Brief Fatigue Inventory (BFI)
This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Measured: Baseline
Fatigue-BFI
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Measured: 10 weeks post-baseline
Fatigue-BFI
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.
Measured: 6 months post-baseline
Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.
Measured: Baseline
Pain- WOMAC
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
Measured: 10 weeks post-baseline
Pain- WOMAC
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
Measured: 6 months post baseline
Secondary outcomes (3)
Physical Function- Six Minute Walk
Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes
Measured: Baseline
Physical Function- Six Minute Walk
This is the distance in feet that people walk over 6 minutes.
Measured: 10 weeks post-baseline
Physical Function- Six Minute Walk
This is the distance people walk in feet over 6 minutes
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2013
- Study completionSep 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Participant
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan L Murphy, ScD OTR, Principal investigator, VA Ann Arbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192516
- Sponsor's protocol ID
- E7557-R
- Acronym
- AIM
- Status last verified
- Mar 2015
- First submitted
- 25 Aug 2010
- Last updated
- 7 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy SL, Schepens Niemiec S, Lyden AK, Kratz AL. Pain, Fatigue, and Physical Activity in Osteoarthritis: The Moderating Effects of Pain- and Fatigue-Related Activity Interference. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S201-9. doi: 10.1016/j.apmr.2015.05.025. Epub 2016 May 17.
PubMed 27207435Murphy SL, Lyden AK, Clary M, Geisser ME, Yung RL, Clauw DJ, Williams DA. Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans. BMC Musculoskelet Disord. 2011 Aug 2;12:177. doi: 10.1186/1471-2474-12-177.
PubMed 21810253
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tailored Activity Pacing for Symptomatic Osteoarthritis
- ClinicalTrials.gov ID
- NCT01192516
- Acronym / sponsor ID
- AIM / E7557-R
- Conditions
- Osteoarthritis, Pain
- Keywords
- Osteoarthritis, Activity Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Posted 19 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this project is to examine effectiveness of a tailored pacing intervention on fatigue, pain, and physical function compared to general pacing intervention and usual care groups. A secondary objective is to evaluate the natural history of symptoms and physical disability over time among people with knee and hip osteoarthritis.
Detailed description
In the United States, osteoarthritis is a growing public health issue and a leading cause of disability among older adults. Almost 50% of users of the Veterans Affairs (VA) system present with osteoarthritis. Veterans are a particularly important group to target for symptom management interventions as they are twice as likely as non-veterans to report chronic joint symptoms and activity limitations. There are few evidence-based symptom management interventions offered by health care professionals, such as occupational and physical therapists, at the time when people are seeking treatment for their symptoms. The proposed activity pacing intervention is individually-tailored to a person's symptom and activity patterns. This tailoring provides a personally-relevant and focused intervention that may help people adopt this strategy into their daily lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Tailored Activity PacingTailored activity pacing |
| Arm 2 | Experimental | Behavioral: General Activity PacingGeneral activity pacing and symptom management (Occupational therapy) |
| Arm 3 | No intervention | –Usual care group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 50 years and older
- Reported pain for at least 3 months
- Mild-moderate pain severity according to the WOMAC pain scale
- Radiographic evidence of knee or hip osteoarthritis (Kellgren-Lawrence score of 2 in at least one joint)
- Community-dwelling (i.e. own home, apartment, senior residence)
Key exclusion criteria (13 listed)
- Self-reported medical history of conditions with pain and/or fatigue as a known and marked symptom (e.g multiple sclerosis, rheumatoid arthritis)
- Medically unstable (e.g. acute conditions or acute presentations of chronic conditions)
- Anemia (hemoglobin of <10 for men and <11 for women)
- Unmanaged thyroid dysfunction (Thyroid stimulating hormone <.035>5.5 mg/dl)
- 2 or more days of complete bed rest within the last month
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 |
|---|---|---|
| Tailored Activity PacingTherapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant. | Behavioural | Arm 1 |
| General Activity PacingTherapeutic intervention using generalized pacing instruction to manage symptoms | Behavioural | Arm 2 |
Primary outcome
Fatigue- Brief Fatigue Inventory (BFI)
Time frame: Baseline
This is a summary measure of fatigue severity and fatigue interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Fatigue-BFI
Time frame: 10 weeks post-baseline
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score is worse fatigue.
Fatigue-BFI
Time frame: 6 months post-baseline
This is a summary measure of fatigue severity and interference items in which the average of 9 items is taken. Each item is rated on a scale of 0 - 10. A higher score indicates worse fatigue.
Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline
This is a summary of reported pain in specific activities. It is 5 questions with answers ranging from 0 - 4. Total possible score is 20 in which a higher score is worse pain.
Pain- WOMAC
Time frame: 10 weeks post-baseline
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
Pain- WOMAC
Time frame: 6 months post baseline
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
3 secondary outcomes
Physical Function- Six Minute Walk
Time frame: Baseline
Physical Function- Six Minute Walk
Time frame: 10 weeks post-baseline
Physical Function- Six Minute Walk
Time frame: 6 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27207435Murphy SL, Schepens Niemiec S, Lyden AK, Kratz AL. Pain, Fatigue, and Physical Activity in Osteoarthritis: The Moderating Effects of Pain- and Fatigue-Related Activity Interference. Arch Phys Med Rehabil. 2016 Sep;97(9 Suppl):S201-9. doi: 10.1016/j.apmr.2015.05.025. Epub 2016 May 17.
- Derived from this study: PubMed 21810253Murphy SL, Lyden AK, Clary M, Geisser ME, Yung RL, Clauw DJ, Williams DA. Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans. BMC Musculoskelet Disord. 2011 Aug 2;12:177. doi: 10.1186/1471-2474-12-177.
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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.
Susan L Murphy, ScD OTR principal investigator
VA Ann Arbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Activity Pacing and General Activity Pacing in people with Osteoarthritis and Pain, run by US Department of Veterans Affairs 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 9 inclusion and 13 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 7 Apr 2015. 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 19 Mar 2015). 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?
Fatigue- Brief Fatigue Inventory (BFI) (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT01192516, which also lists 2 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 7 Apr 2015.