NCT02404974

Brief 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 preferences; and engaging them in an exercise program tailored to meet their needs by a Certified Fitness Trainer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

March 27, 2015

Last Update Submit

January 21, 2016

Conditions

Keywords

physical activity

Outcome Measures

Primary Outcomes (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

    3 months

Secondary Outcomes (4)

  • mean minutes of exercise

    1 and 3 months

  • RAPA

    1 and 3 months

  • confidence as measured on a visual analog scale

    1 and 3 months

  • Pain as measured by the 10 cm visual analog pain scale

    1 and 3 months

Other Outcomes (1)

  • qualitative analysis

    3 months

Study Arms (1)

Exercise

EXPERIMENTAL

This 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.

Behavioral: exercise

Interventions

exerciseBEHAVIORAL

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.

Exercise

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alicia J Zbehlik, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 1, 2015

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations