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Osteoarthritisexercise/OANCT02404974

Using Web-based Tools to Facilitate Tailored Exercise for People With Osteoarthritis

A study testing exercise in people with Osteoarthritis, run by Dartmouth-Hitchcock Medical Center 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

The purpose of this pilot study is to assess the feasibility, acceptability, and potential effectiveness of identifying people with osteoarthritis (OA) who are interested in individualized exercise programs through a web-based osteoarthritis application; assessing their exercise barriers, facilitators, motivators and… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Osteoarthritis
What is being tested?
exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2014to Oct 2015
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 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Exercise <150 minutes a week of mild-moderate activity or < 75 minutes a week of vigorous activity;
  • Age ≥ 50 and ≤ 85;
  • Self-reported uni- or bilateral knee pain in the past 12 months that has been diagnosed as osteoarthritis and is not due to an acute injury;
  • Ability to speak and read English; and
  • Have an established relationship with a Primary Care Provider.

Who cannot join

  • Exercise ≥150 minutes a week of mild-moderate activity or ≥ 75 minutes a week of vigorous activity;
  • Age < 50 years or > 85;
  • Unable to speak and read English;
  • Demonstrate a profound hearing or cognitive impairment;
  • Bilateral knee replacements;
  • Health reasons that preclude their participation in the study such as, but not limited to, traumatic knee injury within the past 12 months, rheumatoid or other inflammatory arthritis, unstable angina, uncompensated heart failure, or their health care provider's recommendation that they not participate; or
  • No established Primary Care Provider.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

Other trials in United States

About this study

The purpose of this pilot study is to assess the feasibility, acceptability, and potential effectiveness of identifying people with osteoarthritis (OA) who are interested in individualized exercise programs through a web-based osteoarthritis application; assessing their exercise barriers, facilitators, motivators and preferences; and engaging them in an exercise program tailored to meet their needs by a Certified Fitness Trainer.

Read the detailed description

The investigators hypothesize that it is feasible and acceptable to identify people with knee pain and osteoarthritis (OA) who are interested in individualized exercise programs through a web-based osteoarthritis treatment diagnosis application; to assess their exercise barriers, facilitators, motivators and preferences; and engage them in an exercise program tailored to meet their needs by a Certified Fitness Trainer.

The investigators will accomplish this by:

  1. Evaluating the feasibility of identifying patients using a web-based preference diagnosis tool (PDx) who have knee pain and osteoarthritis and do not meet exercise guidelines but are interested in tailored exercise programs;
  2. Evaluating the feasibility and acceptability of using self-report assessment tools to identify barriers, facilitators, motivators, and preferences for exercise and to screen participants for health problems that will limit their ability to exercise safely; and
  3. Evaluating the feasibility and potential effectiveness of using the exercise assessment tool by patients with knee pain and osteoarthritis to select an individualized exercise program with the help of a Certified Fitness Trainer and to engage in routine physical exercise.
  4. Study Design

Study design: The investigators will use a pre-post pilot study design. The assessments will be held at either the Dartmouth-Hitchcock Medical Center (One Medical Center Drive, Lebanon NH 03756), or The Dartmouth Centers for Health and Aging (46 Centerra Parkway, Lebanon, NH 03766). Assessments will be conducted by the principal investigator (PI), and/or a research assistant (RA). Consent and approval of the Committee for the Protections of Human Subjects of Dartmouth College will be obtained prior to starting the study. Volunteer non-exercising and under-exercising participants aged 50-85 will be recruited through flyers and provider referral. Recruitment will continue until 10 participants answer "yes" to the exercise question on PDx. Written informed consent will be obtained for all participants.

Aim 1 Methods: Feasibility of identifying patients using a web-based preference diagnosis tool (PDx) who have knee pain and osteoarthritis and do not exercise at recommended levels but are interested in tailored exercise programs.

Volunteer participants will be screened by the RA for eligibility for the study. Demographics of age and sex will be recorded at screening. After obtaining written informed consent, each eligible participant will complete the Preference Diagnosis (PDx) web-based software program and respond "yes" or "no" to the question "I am interested in an exercise program tailored to meet my needs" at the end of the program. PDx is a software application under development at The Dartmouth Center for Health Care Delivery Science (TDC) that uses weighted values and patient assessments of perceived unfavorable aspects or "costs", versus perceived benefits, to develop a profile of preferences around knee OA treatment. An RA (trained by Catalina Gorla of TDC to administer PDx) will coach participants through using the PDx program which will be administered on a lap top computer in a private room. All participants will have their height, weight, and waist circumference measured prior to starting the application using a standardized protocol. Feasibility will be assessed by the proportion of potentially eligible participants who endorse the exercise question within a 3-month period until a maximum of 10 is reached.

Aim 2 Methods: Feasibility and acceptability of using a self-report assessment to identify barriers, facilitators, motivators, and preferences for exercise and to screen participants for health problems that will limit their ability to exercise safely.

Participants who answer "yes" to the exercise question (the final question of the tool) will immediately complete a self-report screening tool: Exercise Barriers, Facilitators, Motivators, and Preferences in Older Adults (appendix A).24 The exercise assessment tool is currently under iterative development and will incorporate expertise of the Certified Fitness Trainer. Participants who are age 69 or less will also complete Personal Assessment of Readiness Questionnaire (PAR-Q) (appendix B).21 As PAR-Q is not validated in adults over 69 years, participants who answer yes to any of the questions (with the excpetion of question 5) on the PAR-Q and those older than 69 will complete a medical screening prior to participation in exercise portion of the study. If question 5 (Do you have any bone or joint problem (for example, back, knee or hip) that could be made worse by a change in your physical activity?) on the PAR-Q is endorsed, the following questions will be asked:

  1. Do you have a bone or joint problem other than osteoarthritis of the knee? If no, then they will be allowed to participate in the study; If yes, they will be asked:
  2. Do you have inflammatory arthritis such as Rheumatoid Arthritis, Psoriatic Arthritis, Gout, or Infectious Arthritis, such as Lyme disease? If yes, they will be excluded from participation.
  3. If uncertain, they will be referred for medical screening prior to participation.

The RA will assist participants in completing assessments, if needed, and help arrange medical follow up. Feasibility will be assessed by the proportion of participants who answered "yes" to the exercise question who complete the Barriers, Facilitators, Motivators and Preferences screening and the PAR-Q and/or medical screening. Acceptability will be assessed by qualitative semi-structured one-hour interviews of the 10 participants at 3 months that will be conducted by the RA based upon questions developed by the research team (Appendix D). Interviews will be transcribed, de-indentified, coded and analyzed for themes using grounded theory.

Aim 3 Methods: Feasibility and potential effectiveness of using the self-report exercise assessment by patients with knee pain and OA to select an individualized exercise program and engage in routine physical exercise with the support of a Certified Fitness Trainer.

Participants will meet with a Certified Fitness Trainer and engage in shared goal setting and selection of a CDC-recommended exercise program for OA that best fits their needs and preferences, specifically addressing any identified barriers. The Trainer will use programs from a vetted list of programs that are appropriate for older adults with knee OA, and modify as needed. This list will be developed with the Certified Fitness Trainer and the PI. The Trainer will be available to answer questions and will contact each participant by phone every two weeks to find out how participants are doing; make adjustments to the program, if needed; and provide motivation and encouragement. Feasibility will be evaluated by quantifying the proportion of participants who complete the assessments within a 3-month period. Potential effectiveness will be evaluated based on pre-post difference in the mean number of self-reported minutes spent in mild, moderate, or vigorous exercise in the previous week; the proportion of participants who have adopted any exercise routine, and change in health goal attainment confidence. Pain as measured on a 10 cm visual analog scale will be collected as an exploratory measure. (see descriptions of measures below).

Conditions
Osteoarthritis
Being tested
exercise
Keywords
physical activity
Medical subject headings
Osteoarthritis, Motor Activity

What participants receive

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

  • exerciseBehavioural

    Participants will meet with a Certified Fitness Trainer and engage in shared goal setting and selection of a CDC-recommended exercise program for OA that best fits their needs and preferences, specifically addressing any identified barriers. The Trainer will use programs from a vetted list of programs that are appropriate for older adults with knee OA, and modify as needed. This list will be developed with the Certified Fitness Trainer and the PI. The Trainer will be available to answer questions and will contact each participant by phone every two weeks to find out how participants are doing; make adjustments to the program, if needed; and provide motivation and encouragement.

Study groups in NCT02404974
Study groupRoleWhat they receive
ExerciseExperimentalThis is a single arm pilot study. All participants who answer yes to interest in exercise question on the web-based osteoarthritis preference tool will be included in the exercise intervention. After completing baseline measures, they will be put in contact with the Fitness Instructor and follow the protocol described.
Receives: Behavioral: exercise

What is being measured

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

  1. Proportion of Participants completing PDx and endorsing the exercise question

    We will record the number of participants who endorse the exercise question over the number of participants who complete PDx

    Measured: 3 months

Secondary outcomes (4)
  1. mean minutes of exercise

    change in mean number of minutes spent in mild, moderate and vigorous exercise

    Measured: 1 and 3 months

  2. RAPA

    change in the Rapid Assessment of Physical Activity (RAPA) at 1 and 3 months

    Measured: 1 and 3 months

  3. confidence as measured on a visual analog scale

    Change in confidence to manage health problems as measured on a visual analog scale

    Measured: 1 and 3 months

  4. Pain as measured by the 10 cm visual analog pain scale

    change in 10 cm visual analog pain scale measured at 1 and 3 months

    Measured: 1 and 3 months

Timeline

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

  1. First posted1 Apr 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02404974
Sponsor's protocol ID
00028445
Acronym
exercise/OA
Status last verified
Jan 2016
First submitted
27 Mar 2015
Last updated
25 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing exercise in people with Osteoarthritis, run by Dartmouth-Hitchcock Medical Center 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 5 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 25 Jan 2016. 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?

Proportion of Participants completing PDx and endorsing the exercise question (time frame: 3 months). 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 25 Jan 2016.

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