NCT02648646

Brief Summary

Purpose: To report the feasibility and to obtain preliminary data on the effects of using an enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis (OA). Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA, are at risk for falls, and are 65+ years old. Procedures (methods): All participants will receive the 6-month enhanced Otago program. The investigators will assemble data: quantifying participant adherence to and safety of the intervention, ascertaining retention of participants for 6 months, determining acceptability of the program, and other validated measures (e.g., number of falls and fall severity, balance measures).

Trial Health

100
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 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 26, 2018

Completed
Last Updated

October 26, 2018

Status Verified

July 1, 2017

Enrollment Period

12 months

First QC Date

November 2, 2015

Results QC Date

April 10, 2017

Last Update Submit

February 6, 2018

Conditions

OsteoarthritisFalls, Accidental

Outcome Measures

Primary Outcomes (4)

  • Participant Adherence to Intervention

    Number of participants who adhere to the intervention.

    6 months

  • Participant Safety With the Intervention

    Number and type of adverse events related to the intervention.

    6 months

  • Retention of Participants

    Number of participants who participate in the study for the full 6 month program.

    6 months

  • Acceptability of the Program

    Descriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.

    6 months

Secondary Outcomes (41)

  • Number of Falls

    Baseline to Month 6

  • Number of People With Severe of Falls

    Baseline to Month 6

  • Berg Balance Scale

    Baseline

  • Four-tests Balance: Feet Together Stand

    Baseline

  • Hand Grip Dynamometry Right Hand

    Baseline

  • +36 more secondary outcomes

Study Arms (1)

Single Arm - Intervention

EXPERIMENTAL

Receives Otago Exercise Programme and Walk with Ease

Other: Otago Exercise Programme and Walk with Ease

Interventions

Otago Exercise Programme and Walk with EaseOTHER

The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.

Single Arm - Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • history of falls
  • knee or hip radiographic OA
  • + years of age
  • normal cognitive function (based on the Mini-Mental State Examination)
  • current knee/hip symptoms

You may not qualify if:

  • hospitalized for stroke, myocardial infarction, or coronary artery revascularization in past 3 months
  • diagnosis of metastatic cancer in the past 3 months
  • terminal illness
  • progressive neurological disorders
  • rheumatoid arthritis
  • severe fibromyalgia
  • other systemic rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Walkingmethyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Yvonne Golightly PT, PhD, Assistant Professor of Epidemiology
Organization
University of North Carolina
golight@email.unc.edu
919-966-0566

Study Officials

  • Yvonne Golightly, PT, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

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

November 2, 2015

First Posted

January 7, 2016

Study Start

November 2, 2015

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

October 26, 2018

Results First Posted

October 26, 2018

Record last verified: 2017-07