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Promoting Physical Activity in Older Adults With Comorbidity

Phase 3
50 Years
Open (Enrolling)
Osteoarthritis, Knee, Hypertension

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Trial Information

Promoting Physical Activity in Older Adults With Comorbidity

Over 9 million Americans have symptomatic osteoarthritis (OA) of the knee, a chronic disease
associated with frequent joint pain, functional limitations, and quadriceps weakness that
intrude upon everyday life. At least half of those with OA of the knee are diagnosed with
hypertension or high blood pressure (HBP), one of the most prevalent risk factors for
cardiovascular disease. Many other individuals with OA of the knee unknowingly have HBP and
remain untreated. Our own work and that of others suggest that persons with OA of the knee
experience reductions in BP when they participate in a regular regimen of physical activity.
Even small decreases in systolic and diastolic BP found with physical activity are
clinically significant, e.g., a 2 mm Hg decrease reduces the risk of stroke by 14% - 17%,
and the risk of coronary heart disease is reduced by 6% - 9%. Yet, only 15% of persons with
OA and 47% with HBP engage in regular physical activity. The purpose of this study is to
investigate how the individually delivered, home-based, 6-month modified Staying Active with
Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address
comorbid HBP, affects lower extremity exercise (flexibility, strengthening, and balance),
fitness walking, functional status, BP, quadriceps strength, pain, fatigue, and
health-related quality of life (HRQoL) in a convenience sample of 224 adults age 50 years or
older with OA of the knee and HBP. Using a randomized controlled, 2-group design, we (1)
hypothesize that at the end of the 6-month intervention period and 6 months after the
intervention period ends those who receive the modified STAR intervention will be more
likely to perform lower extremity exercise, participate in fitness walking, show
improvements in objective functional status, and demonstrate reductions in BP than those who
receive attention-control. Secondarily, we will (2) evaluate the impact of the modified STAR
intervention, compared to attention-control, on subjective functional status, quadriceps
strength, pain, fatigue, and HRQoL at both time points; (3) explore the impact of the
modified STAR intervention, compared to attention-control, on self-efficacy and outcome
expectancy at both time points; (4) explore the relationship between self-efficacy and
outcome expectancy; and (5) explore the extent to which self-efficacy and outcome expectancy
mediate the relationship between the modified STAR intervention and performance of lower
extremity exercise and participation in fitness walking. Data will be analyzed using
repeated measures modeling.

Inclusion Criteria:

- Age 50 years or older.

- Is community dwelling.

- Has osteoarthritis of the knee.

- Has hypertension for which monotherapy or combination pharmacological treatment is

- Able to complete a behavioral run-in consisting of completing questionnaires, using a
7-day electronic-diary, and wearing an ActiGraph accelerometer at the waist for 7

- Has written permission to participate from the physician.

Exclusion Criteria:

- Reports currently doing lower extremity exercise => 2 times/week.

- Reports currently fitness walking => 90 minutes/week.

- Incapable of managing their own treatment regimen.

- Does not have, or cannot use, a telephone or is unwilling to provide a telephone

- Has received cortisone or Synvisc injections in the knee, angioplasty, stents, or a
pacemaker in the past 6 months.

- Reports unstable cardiovascular, pulmonary, or metabolic disease or signs and
symptoms suggestive of cardiovascular, pulmonary, or metabolic disease that restrict

- Has resting systolic blood pressure => 160 mm Hg or diastolic blood pressure => 100
mm Hg.

- Reports other conditions, such as osteoarthritis of the hip, spinal stenosis,
inflammatory arthritis, foot drop, diabetes treated with insulin, or diabetic
complications that may affect performance of lower extremity exercise and
participation in fitness walking.

- Reports current knee conditions, such as meniscus tears and knee ligament ruptures.

- Reports major depression that may impact the ability to fully participate in this

- Is scheduled to undergo a major surgical procedure in the next 13 months.

- Is concurrently participating in a drug or psychoeducational trial that may confound,
or be confounded by, participation in this study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Performance of Lower Extremity Exercise at 25 weeks

Outcome Description:

Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the participant reports completing a lower extremity exercise session and the total number of lower extremity exercises per day performed [sets x repetitions] over a 7-day period).

Outcome Time Frame:

Baseline and at the end of the 6-month intervention period (week 25)

Safety Issue:


Principal Investigator

Elizabeth A. Schlenk, PhD, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:

1 R01 NR010904-01A1



Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Osteoarthritis, Knee
  • Hypertension
  • Osteoarthritis, Knee
  • Hypertension
  • Exercise
  • Physical activity
  • Self Efficacy
  • Patient Compliance
  • Aged
  • Hypertension
  • Osteoarthritis
  • Osteoarthritis, Knee



University of Pittsburgh School of Nursing Pittsburgh, Pennsylvania  15261