Osteoarthritis of the KneeBOOSTNCT01394874
Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?
A study testing TLC in people with Osteoarthritis of the Knee, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- TLC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 15 Jan 2016
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee (ICD-9 Code of 715.16, 715.09 or 715.9)
- lives within interstate 95
- age 55 or older
- English speaking
Who cannot join
- Stroke or heart attack in last 3 months
- Treatment for cancer
- Severe systemic disease
- Medical condition that limits physical activity
- Inflammatory arthritis
- Plans for knee replacement
- Dementia or inability to follow exercise instructions and TLC system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?
The purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- TLC
- Keywords
- osteoarthritis, exercise
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLCBehavioural
Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.
| Study group | Role | What they receive |
|---|---|---|
| Telephone-linked Communication (TLC) | Experimental | This group will receive the computer-based telephone counseling. Receives: Behavioral: TLC |
| Control | No intervention | This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report measure of exercise adherence over the last 3-months on a numeric rating scale
Exercise adherence was assessed by the single self-report item "How would you rate your level of adherence to the prescribed BOOST exercise program, over the last 3 MONTHS?" Participants selected a number from 0 (not at all) to 10 (completely as instructed). Higher scores reflect better adherence.
Measured: 24 month
Secondary outcomes (4)
24 -month change in self-report of pain and function using the WOMAC index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting on/off toilet, heavy domestic duties, light domestic duties Responses to individual questions [between 0 (extreme) and 4 (None)] are summed to a raw score ranging from 0 (worst) to 96 (best) and then normalized to a WOMAC Score of between 0 (worst) to 100 (best). The difference in pain and function subscale values between the measures following the exercise class and the 24-month follow-up were used for secondary outcomes.
Measured: post the 1-month exercise class, 24 months
Quadriceps strength
Isokinetic quadriceps strength will be assessed with a Biodex
Measured: Change in quadriceps strength from baseline to 24 months.
Timed Physical Function tasks
Timed physical function tasks will include a timed get up and go, timed stair ascent and descent, and a 5 and 10 chair stand time. We will examine the association of adherence, as a dichotomous and continuous variable, to change in timed physical function using logistic and linear regression, respectively.
Measured: Change in timed physical function task over 24 months
Exercise quality
The outcome will be assessed at the end of the 24 month follow-up period as the number of calendar periods (1 month per calendar period) that the participant exercises at least half the number of prescribed sessions (a minimum of 6 out of 12 over a 4 week period) with the agreed upon level of intensity.
Measured: Average measure of exercise quality over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJul 2011
- Primary completion15 Jan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Kristin Baker, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394874
- Sponsor's protocol ID
- H133B100003-2
- Acronym
- BOOST
- Status last verified
- Jan 2019
- First submitted
- 21 Jun 2011
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Baker K, LaValley MP, Brown C, Felson DT, Ledingham A, Keysor JJ. Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial. Arthritis Care Res (Hoboken). 2020 Jul;72(7):982-990. doi: 10.1002/acr.23921.
PubMed 31074576Chang FH, Jette AM, Slavin MD, Baker K, Ni P, Keysor JJ. Detecting functional change in response to exercise in knee osteoarthritis: a comparison of two computerized adaptive tests. BMC Musculoskelet Disord. 2018 Jan 23;19(1):29. doi: 10.1186/s12891-018-1942-9.
PubMed 29361920
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?
- ClinicalTrials.gov ID
- NCT01394874
- Acronym / sponsor ID
- BOOST / H133B100003-2
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jul 2011 (actual)
- Primary completion
- 15 Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 15 Jul 2011 (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 research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-linked Communication (TLC) | Experimental | Behavioral: TLCThis group will receive the computer-based telephone counseling. |
| Control | No intervention | –This is the control group. They will receive the exercise class, however, they will not receive the telephone counseling. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- osteoarthritis of the knee (ICD-9 Code of 715.16, 715.09 or 715.9)
- lives within interstate 95
- age 55 or older
- English speaking
Key exclusion criteria (7 listed)
- Stroke or heart attack in last 3 months
- Treatment for cancer
- Severe systemic disease
- Medical condition that limits physical activity
- Inflammatory arthritis
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 |
|---|---|---|
| TLCComputer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time. | Behavioural | Telephone-linked Communication (TLC) |
Primary outcome
Self-report measure of exercise adherence over the last 3-months on a numeric rating scale
Time frame: 24 month
Exercise adherence was assessed by the single self-report item "How would you rate your level of adherence to the prescribed BOOST exercise program, over the last 3 MONTHS?" Participants selected a number from 0 (not at all) to 10 (completely as instructed). Higher scores reflect better adherence.
4 secondary outcomes
24 -month change in self-report of pain and function using the WOMAC index
Time frame: post the 1-month exercise class, 24 months
Quadriceps strength
Time frame: Change in quadriceps strength from baseline to 24 months.
Timed Physical Function tasks
Time frame: Change in timed physical function task over 24 months
Exercise quality
Time frame: Average measure of exercise quality over 24 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 17 Jan 2019.
- Derived from this study: PubMed 31074576Baker K, LaValley MP, Brown C, Felson DT, Ledingham A, Keysor JJ. Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial. Arthritis Care Res (Hoboken). 2020 Jul;72(7):982-990. doi: 10.1002/acr.23921.
- Derived from this study: PubMed 29361920Chang FH, Jette AM, Slavin MD, Baker K, Ni P, Keysor JJ. Detecting functional change in response to exercise in knee osteoarthritis: a comparison of two computerized adaptive tests. BMC Musculoskelet Disord. 2018 Jan 23;19(1):29. doi: 10.1186/s12891-018-1942-9.
- Individual participant dataSharing planned: No
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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.
Kristin Baker, PhD principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLC in people with Osteoarthritis of the Knee, run by Boston University Charles River Campus 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 4 inclusion and 7 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 17 Jan 2019. 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?
Self-report measure of exercise adherence over the last 3-months on a numeric rating scale (time frame: 24 month). 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 NCT01394874, 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 17 Jan 2019.