Skip to main content
OpenTrials
Completed

NCT Number: NCT00126737

Home-Based Exercise and Weight Control Program for Pain Control in Overweight Elderly With Osteoarthritis of the Knee

The purpose of this study is to determine whether a home-based exercise and weight control program applied to elderly overweight individuals with painful osteoarthritis of the knee, would result in pain reduction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Diseases Agnosia Arthritis Behavior Body Weight Body Weight Changes Chronic Disease Disease Attributes Joint Diseases Motor Activity Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoarthritis Overnutrition Overweight Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms Weight Loss

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-3030, United States

About this study

Osteoarthritis (OA) is the most common chronic disease in the United States (U.S.). Arthritis is a leading chronic illness among older adults in the U.S. Approximately 40% of individuals above 60 yr of age have OA of the knee. The primary objective of the proposed study is to determine whether individuals who are overweight with OA of the knee and who complete a 24-week home-based exercise program combined with a weight control intervention program will report significantly less pain (as measured by the WOMAC) than volunteers who participate in home-based exercise (Ex) only, weight control intervention (WC) only, or standard clinical care (C). The secondary objectives of the proposed research are to determine whether overweight individuals with OA of the knee who complete the Ex+WC program, when compared to subjects who are randomly assigned to a E, WC or C groups, demonstrate significant improvement in the following health risk profile variables: (a) improved physical function (measured by the Functional Performance Inventory), (b) improved capacity to perform stair climbing and descending, (c) improved strength, (d) increased lean body mass, (e) increase in physical activity at home (measured by pedometer step count). The proposed clinical trial will utilize a prospective, randomized two by two factorial design. Descriptive and ancova statistical method will be applied for data analyses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male & female 50 years old
  • Diagnosis of osteoarthritis by American College of Rheumatology criteria
  • Knee radiographs of Kellgren and Lawrence grade 2-4
  • American Arthritis Association functional class 1-3
  • Body mass index of 27

Exclusion criteria

  • Knee arthritis which did not meet American College of Rheumatology (ACR) OA criteria
  • Unable to engage in exercise or follow instruction
  • Limited shoulder range of motion

Treatment and study plan

Weight Control Nutritional Program

Other

a week of food diary and information about dietary fat intake and proper proportions of vegetables.

Other names: pole striding walking exercise

Home-based exercise program

Other

24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.

Primary outcomes

  1. WOMAC Function

    Time frame: Between Base-line and 24 weeks

    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is used to measure pain, function, and stiffness in patients with OA of the knee. At 24 weeks post-baseline, the average change in score was measured. We used the Function Scale only for this study. The Function Scale has 17 items, the responses are in Likert scale; namely 0=No difficulty, 1=Slight, 2=Moderate, 3= Very, 4=Extremely. The total score ranges from 0 to 68, a higher score means worse functioning. A score of 68 indicates extremely difficult in functioning.

  2. Physical Scale SF-36v

    Time frame: Between Base-line and 24 weeks

    The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. physical health). The average change in score 24 weeks post-baseline was measured. Physical Health consists of 4 scales, Physical Function (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items). The Physical Health component is a summary measure of scales, and the scores ranges from 0 to 100, a score of 50 is the normative average of general health. Lower scores correspond to worse physical health, higher scores correspond to better physical health.

  3. Mental Scale SF-36v

    Time frame: Between Base-line and 24 weeks

    The Rand Short Form-36 (SF-36) was used to measure health related quality of life (i.e. mental health). The average change in score 24 weeks post-baseline was measured. Mental Health component consisted of 4 scales; these are the scales: Vitality ( 4 items), Social functioning (2 items), Role Emotional (3 items), and Mental Health (5 items). The mental health summary measures is called the Mental health component of SF36v. It was used to measure health related quality of life (i.e. mental health). The total score ranged from 0 to 100, a score of 50 is the normative average for general mental health. Lower scores correspond to worse mental health status, higher scores correspond to better mental health status.

Secondary outcomes

  1. Walking Distance

    Time frame: Between Base-line and 24 weeks

    Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.

  2. Stair Total (Climb, Descend)

    Time frame: Between Base-line and 24 Weeks

    Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. The average change in total number of steps 24 weeks post-baseline was measured.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Aug 4, 2005
Registry last updated
Jan 1, 2015

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.