Staying Active With Arthritis: RCT of Physical Activity for Older Adults With Osteoarthritis and Hypertension

NCT01280903 | Completed Results DMC

• 2 other identifiers: PRO09110029R01NR010904-01A1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (12)

• Performance of Lower Extremity Exercise at 25 Weeks

  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 \[repetitions x sets\] over a 7-day period).

  At the end of the 6-month intervention period (week 25)

• Participation in Fitness Walking at 25 Weeks

  Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.

  At the end of the 6-month intervention period (week 25)

• Objective Functional Status by the 6-minute Walk at 25 Weeks

  Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.

  At the end of the 6-month intervention period (week 25)

• Objective Functional Status by the Short Physical Performance Battery at 25 Weeks

  Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.

  At the end of the 6-month intervention period (week 25)

• Systolic Blood Pressure at 25 Weeks

  Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  At the end of the 6-month intervention period (week 25)

• Diastolic Blood Pressure at 25 Weeks

  Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  At the end of the 6-month intervention period (week 25)

• Performance of Lower Extremity Exercise at 52 Weeks

  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 \[repetitions x sets\] over a 7-day period).

  6 months after the intervention period ends (week 52)

• Participation in Fitness Walking at 52 Weeks

  Measured by the ActiGraph accelerometer in terms of mean daily activity minutes of none to very low, light, and moderate-to-vigorous activity counts summarized over a 7-day period.

  6 months after the intervention period ends (week 52)

• Objective Functional Status by the 6-minute Walk at 52 Weeks

  Measured by the 6-minute walk (yards) as part of the performance-based functional status assessment.

  6 months after the intervention period ends (week 52)

• Objective Functional Status by the Short Physical Performance Battery at 52 Weeks

  Measured by the Short Physical Performance Battery (total scale score) as part of the performance-based functional status assessment; subscale scores are summed for a total scale score; the scale score range is 0-13; higher scores are better.

  6 months after the intervention period ends (week 52)

• Systolic Blood Pressure at 52 Weeks

  Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  6 months after the intervention period ends (week 52)

• Diastolic Blood Pressure at 52 Weeks

  Measured by the OMRON HEM-907XL automatic professional digital blood pressure monitor in mm Hg.

  6 months after the intervention period ends (week 52)

Secondary Outcomes (18)

• Subjective Functional Status at 25 Weeks

  At the end of the 6-month intervention period (week 25)

• Quadriceps Strength at 25 Weeks

  At the end of the 6-month intervention period (week 25)

• Pain by the Pain Subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at 25 Weeks

  At the end of the 6-month intervention period (week 25)

• Pain by the Bodily Pain Subscale of the Short Form-36v2 at 25 Weeks

  At the end of the 6-month intervention period (week 25)

• Fatigue at 25 Weeks

  At the end of the 6-month intervention period (week 25)

Study Arms (2)

STAR Intervention

EXPERIMENTAL

Staying Active with Arthritis Intervention

Behavioral: STAR Intervention

Attention-Control

PLACEBO COMPARATOR

Senior Health Information Intervention

Behavioral: Attention-Control

Interventions

STAR Intervention BEHAVIORAL

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.

STAR Intervention

Attention-Control BEHAVIORAL

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.

Attention-Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• Schlenk EA, Sereika SM, Martire LM, Shi X. Older adults' social network and support and its association with physical activity. Geriatr Nurs. 2021 Mar-Apr;42(2):517-523. doi: 10.1016/j.gerinurse.2020.09.006. Epub 2020 Oct 7.

  PMID: 33039202 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Hypertension; Motor Activity; Patient Compliance

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Results Point of Contact

• Title: Elizabeth A. Schlenk
• Organization: University of Pittsburgh

els100@pitt.edu

412-624-4103

Study Officials

• Elizabeth A. Schlenk, PhD, RN

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: January 21, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 19, 2024
• Results First Posted: January 31, 2018

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)