Staying Active With Arthritis (STAR)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elizabeth Schlenk, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01280903
First received: December 17, 2010
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The purpose of the Staying Active with Arthritis (STAR) research study is to determine if a 6-month program will improve leg exercise, fitness walking, and clinical outcomes (function, blood pressure, leg strength, pain, fatigue, and health-related quality of life) in older adults with osteoarthritis of the knee and high blood pressure.


Condition Intervention Phase
Osteoarthritis, Knee
Hypertension
Behavioral: STAR Intervention
Behavioral: Attention-Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Physical Activity in Older Adults With Comorbidity

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change from Baseline in Performance of Lower Extremity Exercise at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline in Participation in Fitness Walking at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the ActiGraph accelerometer in terms of total activity counts per minute and minutes per day of light, moderate, and vigorous physical activity summarized over a 7-day period.

  • Change from Baseline in Objective Functional Status at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the 6-minute walk and Short Physical Performance Battery as part of the performance-based functional status assessment.

  • Change from Baseline in Systolic Blood Pressure at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the automated blood pressure monitor in mm Hg.

  • Change from Baseline in Diastolic Blood Pressure at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the automated blood pressure monitor in mm Hg.

  • Change from Baseline in Performance of Lower Extremity Exercise at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the electronic-diary in terms of the total volume of lower extremity exercise (i.e., the number of days the subject 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).

  • Change from Baseline in Participation in Fitness Walking at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the ActiGraph accelerometer in terms of total activity counts per minute and minutes per day of light, moderate, and vigorous physical activity summarized over a 7-day period.

  • Change from Baseline in Objective Functional Status at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the 6-minute walk and Short Physical Performance Battery as part of the performance-based functional status assessment.

  • Change from Baseline in Systolic Blood Pressure at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the automated blood pressure monitor in mm Hg.

  • Change from Baseline in Diastolic Blood Pressure at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the automated blood pressure monitor in mm Hg.


Secondary Outcome Measures:
  • Change from Baseline in Subjective Functional Status at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  • Change from Baseline in Quadriceps Strength at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the MicroFET2 hand-held dynamometer.

  • Change from Baseline in Pain at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Bodily Pain subscale of the Short Form-36v2 and the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  • Change from Baseline in Fatigue at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Brief Fatigue Inventory.

  • Change from Baseline in Health-Related Quality of Life at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Short Form-36v2.

  • Change from Baseline in Self-Efficacy at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Self-Efficacy Scale (Barriers Self-Efficacy subscale and Exercise Self-Efficacy subscale) and the Arthritis Self-Efficacy Scale (Pain subscale, Function subscale, and Other Symptoms subscale).

  • Change from Baseline in Outcome Expectancy at 25 weeks [ Time Frame: Baseline and at the end of the 6-month intervention period (week 25) ] [ Designated as safety issue: No ]
    Measured by the Perceived Therapeutic Efficacy Scale (Exercise and Arthritis version and Exercise and High Blood Pressure version).

  • Change from Baseline in Subjective Functional Status at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Physical Function subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  • Change from Baseline in Quadriceps Strength at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the MicroFET2 hand-held dynamometer.

  • Change from Baseline in Pain at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Bodily Pain subscale of the Short Form-36v2 and the Pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.

  • Change from Baseline in Fatigue at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Brief Fatigue Inventory.

  • Change from Baseline in Health-Related Quality of Life at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Short Form-36v2.

  • Change from Baseline in Self-Efficacy at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Self-Efficacy Scale (Barriers Self-Efficacy subscale and Exercise Self-Efficacy subscale) and the Arthritis Self-Efficacy Scale (Pain subscale, Function subscale, and Other Symptoms subscale).

  • Change from Baseline in Outcome Expectancy at 52 weeks [ Time Frame: Baseline and 6 months after the intervention period ends (week 52) ] [ Designated as safety issue: No ]
    Measured by the Perceived Therapeutic Efficacy Scale (Exercise and Arthritis version and Exercise and High Blood Pressure version).


Estimated Enrollment: 224
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STAR Intervention
Staying Active with Arthritis Intervention
Behavioral: STAR Intervention
The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.
Placebo Comparator: Attention-Control
Senior Health Information Intervention
Behavioral: Attention-Control
Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 prescribed.
  • 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 days.
  • 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 number.
  • 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 activity.
  • 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 study.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280903

Locations
United States, Pennsylvania
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Elizabeth A. Schlenk, PhD, RN University of Pittsburgh
  More Information

No publications provided

Responsible Party: Elizabeth Schlenk, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01280903     History of Changes
Other Study ID Numbers: 1 R01 NR010904-01A1, R01NR010904-01A1
Study First Received: December 17, 2010
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Osteoarthritis, Knee
Hypertension
Exercise
Physical activity
Self Efficacy
Patient Compliance
Aged

Additional relevant MeSH terms:
Hypertension
Osteoarthritis
Osteoarthritis, Knee
Vascular Diseases
Cardiovascular Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014