Skip to main content
OpenTrials
Completed

NCT Number: NCT03180008

Fit and Strong! Plus Comparative Effectiveness Trial

This randomized controlled trial is comparing outcomes of customary Fit and Strong!, to Fit and Strong! Plus, an enhanced version of the program that incorporates weight management. We hypothesize that Fit and Strong! Plus participants will show improved diet behaviors at 2, 6, 12, and 18 months that will be accompanied by a significant 5% weight loss at 6 months and maintained to 18 months, compared to participants in customary Fit and Strong!.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of symptoms of lower extremity osteoarthritis
  • Age 60 or older
  • Not currently participating in a regular physical activity program
  • BMI 25-50
  • Able to attend Fit and Strong! classes

Exclusion criteria

  • Score of 3 or greater on Mental Status Questionnaire
  • Recent hip or knee surgery
  • Recent steroid injection into hip or knee
  • Diagnosis of rheumatoid arthritis
  • Uncontrolled diabetes
  • Unspecified health conditions that may interfere with exercise

Treatment and study plan

Fit and Strong!

Behavioral

Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.

Fit and Strong! Plus

Behavioral

The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.

Primary outcomes

  1. Dietary Intake

    Time frame: 2, 6, 12, and 18 months

    The Healthy Eating Index 2010 (HEI-2010) measures diet quality based on the Dietary Guidelines for Americans. HEI-2010 total scores range from 0 to 100 points, with a higher score signifying superior diet quality.

  2. Body Weight

    Time frame: 2, 6, 12, and 18 months

    A change in body weight (kilograms) measured using a calibrated digital scale (Tanita).

Secondary outcomes

  1. Physical Activity Engagement

    Time frame: 2, 6, 12, and 18 months

    A change in Physical activity was assessed using the Physical Activity Scale for the Elderly (PASE). Scored on a scale of 0 - 400, a higher score indicates greater PA.

  2. Lower Extremity Pain

    Time frame: Baseline, 2, 6, 12, and 18 months

    A change in Osteoarthritis "lower extremity pain" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Pain (5 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0-20.

  3. Lower Extremity Stiffness

    Time frame: Baseline, 2, 6, 12, and 18 months

    A change in Osteoarthritis "lower extremity stiffness" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Stiffness (2 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 8.

  4. Lower Extremity Physical Function

    Time frame: Baseline, 2, 6, 12, and 18 months

    A change in Osteoarthritis "lower extremity physical function" symptoms were measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC is a self-report instrument that has been well-validated and used widely with individuals with osteoarthritis. Lower extremity physical function (17 items) was rated on a Likert scale ranging from 0 (none) to four. Higher scores indicate more severe osteoarthritis symptoms, scores range from 0 to 68.

  5. Lower Extremity Muscle Strength

    Time frame: Baseline, 2, 6, 12, and 18 months

    A change in Lower Extremity Muscle Strength was measured by a Sit-Stand test that measures the number of full stands from a seated position a participant can complete in 30 s with arms folded across the chest. A higher score reflects better performance.

  6. Physical Endurance

    Time frame: Baseline, 2, 6, 12, and 18 months

    A change in Physical Endurance was measured by the 6-minute Distance Walk, which is a self-paced timed test of the total distance a person can walk in six minutes. A higher score reflects better performance.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Comparative Effectiveness of Customary Fit and Strong! vs. Fit and Strong Plus!

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.