An interventional study of Tailored Activity Pacing and General Activity Pacing in Osteoarthritis and Pain, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 195 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tailored activity pacing
Behavioral: Tailored Activity Pacing
General activity pacing and symptom management (Occupational therapy)
Behavioral: General Activity Pacing
Usual care group
Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
Therapeutic intervention using generalized pacing instruction to manage symptoms
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Pain- WOMAC
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
Time frame: 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.
Time frame: 6 months post baseline
Physical Function- Six Minute Walk
Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes
Time frame: Baseline
Physical Function- Six Minute Walk
This is the distance in feet that people walk over 6 minutes.
Time frame: 10 weeks post-baseline
Physical Function- Six Minute Walk
This is the distance people walk in feet over 6 minutes
Time frame: 6 months post baseline
Potential participants were recruited through fliers and advertisements.
| Milestone | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Started | 66 | 66 | 63 |
| Completed | 46 | 49 | 55 |
| Not completed | 20 | 17 | 8 |
| Withdrew: Lost to follow-up | 7 | 10 | 7 |
| Withdrew: Withdrawal by subject | 4 | 4 | 1 |
| Withdrew: Started new treatment | 5 | 1 | 0 |
| Withdrew: Unable to follow actiwatch instructions | 4 | 2 | 0 |
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.
| units on a scale | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Fatigue- Brief Fatigue Inventory (BFI) | 3.06 ± 2.34 | 3.18 ± 2.45 | 2.70 ± 2.31 |
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.
| units on a scale | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Fatigue-BFI | 3.35 ± 2.13 | 3.09 ± 2.14 | 2.98 ± 2.28 |
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.
| units on a scale | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Fatigue-BFI | 3.30 ± 2.36 | 2.90 ± 1.98 | 2.83 ± 2.26 |
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.
| units on a scale | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| Pain- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 8.23 ± 2.99 | 8.19 ± 3.37 | 8.27 ± 3.32 |
This is a 5-item pain scale in which scores from 0 - 4 are summed. A higher score indicates more pain.
| units on a scale | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Pain- WOMAC | 8.10 ± 3.43 | 7.16 ± 3.11 | 7.83 ± 3.46 |
This is a 5 item pain scale in which items on a scale of 0 - 4 are summed. A higher score means more pain.
| units on a scale | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Pain- WOMAC | 7.63 ± 3.57 | 7.33 ± 2.76 | 6.68 ± 3.29 |
Six minute walk is the distance (in feet) that people walk at a usual pace over 6 minutes
| feet | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Physical Function- Six Minute Walk | 1185.3 ± 263.3 | 1208.6 ± 255.2 | 1209.4 ± 260.1 |
This is the distance in feet that people walk over 6 minutes.
| feet | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Physical Function- Six Minute Walk | 1200.5 ± 260.1 | 1249.4 ± 217.3 | 1236.1 ± 246.1 |
This is the distance people walk in feet over 6 minutes
| feet | Tailored Activity Pacing | General Activity Pacing | Usual Care Group |
|---|---|---|---|
| Physical Function- Six Minute Walk | 1225.4 ± 240.1 | 1264.3 ± 192.9 | 1222.4 ± 265.6 |
Collected over Data were collected from baseline through completion of Time 3 outcome measures at 6 months. Non-serious events are listed at a 4.55% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 0/66 (0%) | 3/66 (4.5%) |
| Arm 2 | — | 0/66 (0%) | 3/66 (4.5%) |
| Arm 3 | — | 0/63 (0%) | 1/63 (1.6%) |
| Event | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| x-ray mistakesMusculoskeletal and connective tissue disorders | 3/66 | 3/66 | 1/63 |
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 39 | 36 | 36 | 111 |
| >=65 years | 27 | 30 | 27 | 84 |
| Age, Continuous(years) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Mean | 64.5 ± 8.1 | 64.1 ± 8.3 | 65.8 ± 8.7 | 64.8 ± 8.4 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Female | 40 | 41 | 39 | 120 |
| Male | 26 | 25 | 24 | 75 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| United States | 66 | 66 | 63 | 195 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs