Chronic Diseases, Obesity, Osteoarthritis, Pain
Conditions
Keywords
Elderly, Exercise, lean body mass, muscle strength, Nutrition program, Pain control, stair climb, walking distance, weight loss
Brief summary
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.
Detailed description
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.
Interventions
OTHERWeight Control Nutritional Program
a week of food diary and information about dietary fat intake and proper proportions of vegetables.
24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Function | 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. |
| Physical Scale SF-36v | 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. |
| Mental Scale SF-36v | 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
| Measure | Time frame | Description |
|---|---|---|
| Walking Distance | 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. |
| Stair Total (Climb, Descend) | 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. |
Countries
United States
Participant flow
Recruitment details
The study sample was recruited from the general medicine and arthritis clinics of VA Hospital Hines, Illinois, and several non-VA affiliated community-based clinics.
Pre-assignment details
143 subjects were screened for eligibility in the study. 33 subjects were excluded; reasons for exclusion: 7 = cardiovascular (CV) , 3 = hospitalized, 1= knee surgery, 6 = no transport, 5 = impaired cognition, 4 = spouse illness, 4= moved, and 3 = disagree with assignment/not interested. 110 subjects were then randomized.
Participants by arm
| Arm | Count |
|---|---|
| Weight Control Nutritional and Home-based Exercise Pro Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises. | 28 |
| Weight Control Nutritional Program Group assigned to a Weight Control Nutritional Program (WC).
Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables. | 27 |
| Home-based Exercise Program Group assigned to a Home-based exercise program (Ex).
Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises. | 30 |
| Usual Care Usual care and non-specific health information (C). No intervention. | 25 |
| Total | 110 |
Baseline characteristics
| Characteristic | Total | Usual Care | Home-based Exercise Program | Weight Control Nutritional Program | Weight Control Nutritional and Home-based Exercise Pro |
|---|---|---|---|---|---|
| 36 Items Short Form Survey Instrument (SF-36v) Mental Scale | 50.1 score STANDARD_DEVIATION 10.8 | 48.3 score STANDARD_DEVIATION 11.5 | 48.2 score STANDARD_DEVIATION 11.4 | 51.9 score STANDARD_DEVIATION 9.8 | 52.1 score STANDARD_DEVIATION 10.6 |
| Age, Continuous | 67.9 years STANDARD_DEVIATION 8.4 | 69.5 years STANDARD_DEVIATION 8.5 | 65.8 years STANDARD_DEVIATION 7.6 | 66.3 years STANDARD_DEVIATION 7.3 | 70.3 years STANDARD_DEVIATION 9.6 |
| BMI at Baseline | 34.4 kg/m^2 STANDARD_DEVIATION 5.9 | 32.8 kg/m^2 STANDARD_DEVIATION 5.1 | 34.3 kg/m^2 STANDARD_DEVIATION 5.4 | 36.8 kg/m^2 STANDARD_DEVIATION 6.2 | 33.8 kg/m^2 STANDARD_DEVIATION 6.4 |
| Duration of OA | 10.0 years STANDARD_DEVIATION 10.1 | 10.0 years STANDARD_DEVIATION 9.8 | 11.5 years STANDARD_DEVIATION 13.2 | 9.4 years STANDARD_DEVIATION 6 | 9.1 years STANDARD_DEVIATION 10.4 |
| Married Married | 67 participants | 16 participants | 20 participants | 18 participants | 13 participants |
| Married Not-Married | 43 participants | 9 participants | 10 participants | 9 participants | 15 participants |
| Race/Ethnicity, Customized Non-white | 11 participants | 1 participants | 2 participants | 4 participants | 4 participants |
| Race/Ethnicity, Customized White | 99 participants | 24 participants | 28 participants | 23 participants | 24 participants |
| Sex: Female, Male Female | 11 Participants | 1 Participants | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 99 Participants | 24 Participants | 27 Participants | 25 Participants | 23 Participants |
| SF-36v Physical Scale | 36.9 score STANDARD_DEVIATION 8.3 | 36.4 score STANDARD_DEVIATION 9 | 35.7 score STANDARD_DEVIATION 8.2 | 41.1 score STANDARD_DEVIATION 7.2 | 34.7 score STANDARD_DEVIATION 7.8 |
| Stair Total (climb, descend) | 176.0 stairs STANDARD_DEVIATION 52.8 | 171.7 stairs STANDARD_DEVIATION 52.8 | 182.9 stairs STANDARD_DEVIATION 54.1 | 181.0 stairs STANDARD_DEVIATION 53.2 | 167.7 stairs STANDARD_DEVIATION 52.5 |
| Walking Distance | 443.8 meters STANDARD_DEVIATION 102.7 | 435.1 meters STANDARD_DEVIATION 82.4 | 476.9 meters STANDARD_DEVIATION 101.4 | 445.1 meters STANDARD_DEVIATION 125.4 | 414.9 meters STANDARD_DEVIATION 92.6 |
| WOMAC Function | 41.9 Score STANDARD_DEVIATION 12.2 | 44.4 Score STANDARD_DEVIATION 14.8 | 40.3 Score STANDARD_DEVIATION 10.6 | 39.2 Score STANDARD_DEVIATION 12 | 44.0 Score STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 28 | 3 / 27 | 7 / 30 | 6 / 25 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 30 | 0 / 25 |
Outcome results
Primary
Mental Scale SF-36v
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.
Time frame: Between Base-line and 24 weeks
Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program and 3 in Usual Care
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Control Nutritional and Home-based Exercise Pro | Mental Scale SF-36v | 0.28 Change in Score |
| Weight Control Nutritional Program | Mental Scale SF-36v | 2.62 Change in Score |
| Home-based Exercise Program | Mental Scale SF-36v | -0.23 Change in Score |
| Usual Care | Mental Scale SF-36v | -2.64 Change in Score |
Primary
Physical Scale SF-36v
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.
Time frame: Between Base-line and 24 weeks
Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 3 in the Usual Care.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Control Nutritional and Home-based Exercise Pro | Physical Scale SF-36v | 5.51 Change in score |
| Weight Control Nutritional Program | Physical Scale SF-36v | 0.56 Change in score |
| Home-based Exercise Program | Physical Scale SF-36v | 3.58 Change in score |
| Usual Care | Physical Scale SF-36v | 0.34 Change in score |
p-value: 0.030795% CI: [0.432, 8.659]ANCOVA
Primary
WOMAC Function
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.
Time frame: Between Base-line and 24 weeks
Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 3 in Weight Control Nutritional Program, 1 in Home-based exercise program and 1 in Usual Care.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Control Nutritional and Home-based Exercise Pro | WOMAC Function | -10.4 Change in Score |
| Weight Control Nutritional Program | WOMAC Function | -4.8 Change in Score |
| Home-based Exercise Program | WOMAC Function | -4.9 Change in Score |
| Usual Care | WOMAC Function | -1.6 Change in Score |
p-value: 0.012995% CI: [-11.41, -1.38]ANCOVA
p-value: 0.053595% CI: [-10.43, 0.079]ANCOVA
Secondary
Stair Total (Climb, Descend)
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.
Time frame: Between Base-line and 24 Weeks
Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 2 in Weight control Nutritional and home -based Exercise program, 1 in Weight Control Nutritional Program, 1 in Home-based exercise Program and 1 in Usual Care.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Control Nutritional and Home-based Exercise Pro | Stair Total (Climb, Descend) | 39.75 Change in Steps |
| Weight Control Nutritional Program | Stair Total (Climb, Descend) | 23.61 Change in Steps |
| Home-based Exercise Program | Stair Total (Climb, Descend) | 40.48 Change in Steps |
| Usual Care | Stair Total (Climb, Descend) | 9.06 Change in Steps |
p-value: 0.001895% CI: [10.767, 45.492]ANCOVA
p-value: 0.002495% CI: [9.675, 43.746]ANCOVA
p-value: 0.036895% CI: [1.169, 36.325]ANCOVA
Secondary
Walking Distance
Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured.
Time frame: Between Base-line and 24 weeks
Population: There are discrepancies in the numbers of participants being analyzed due to incomplete data collection. the disprepancies are in the following groups: 1 in Weight control Nutritional and home -based Exercise program, 2 in Weight Control Nutritional Program.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Weight Control Nutritional and Home-based Exercise Pro | Walking Distance | 71.64 Change in Distance (m) |
| Weight Control Nutritional Program | Walking Distance | 17.42 Change in Distance (m) |
| Home-based Exercise Program | Walking Distance | 42.08 Change in Distance (m) |
| Usual Care | Walking Distance | 6.55 Change in Distance (m) |
p-value: 0.015895% CI: [7.655, 72.215]ANCOVA
p-value: 0.000295% CI: [29.97, 94.54]ANCOVA
p-value: 0.005695% CI: [12.54, 75.36]ANCOVA