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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC). |
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| Arm 2 | Active Comparator | Group assigned to a Weight Control Nutritional Program (WC). |
|
| Arm 3 | Active Comparator | Group assigned to a home-based exercise program (Ex). |
|
| Arm 4 | No Intervention | Usual care and non- specific health information (C). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Control Nutritional Program | Other | a week of food diary and information about dietary fat intake and proper proportions of vegetables. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between Base-line and 24 weeks |
| 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. | Between Base-line and 24 weeks |
| 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. | Between Base-line and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Distance | Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured. | Between Base-line and 24 weeks |
| Stair Total (Climb, Descend) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elly Budiman-Mak, MS MPH MD | Edward Hines Jr. VA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital | Hines | Illinois | 60141-3030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18712641 | Result | Collins E, O'Connell S, Jelinek C, Miskevics S, Budiman-Mak E. Evaluation of psychometric properties of Walking Impairment Questionnaire in overweight patients with osteoarthritis of knee. J Rehabil Res Dev. 2008;45(4):559-66. doi: 10.1682/jrrd.2007.04.0053. | |
| 20665344 | Result | Wolf S, Foley S, Budiman-Mak E, Moritz T, O'Connell S, Jelinek C, Collins EG. Predictors of weight loss in overweight veterans with knee osteoarthritis who participated in a clinical trial. J Rehabil Res Dev. 2010;47(3):171-81. doi: 10.1682/jrrd.2009.08.0136. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight Control Nutritional and Home-based Exercise Program | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Home-based exercise program | Other | 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises. |
|
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.
| Between Base-line and 24 Weeks |
| 20437315 | Result | Possley D, Budiman-Mak E, O'Connell S, Jelinek C, Collins EG. Relationship between depression and functional measures in overweight and obese persons with osteoarthritis of the knee. J Rehabil Res Dev. 2009;46(9):1091-8. doi: 10.1682/jrrd.2009.03.0024. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Usual Care | Usual care and non-specific health information (C). No intervention. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Usual Care | Usual care and non-specific health information (C). No intervention. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| BMI at Baseline | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Duration of OA | Duration of Osteoarthritis (OA) of the knee | Mean | Standard Deviation | years |
| ||||||||||||||
| Walking Distance | Average distance walked in six minutes. | Mean | Standard Deviation | meters |
| ||||||||||||||
| WOMAC Function | Western Ontario and McMaster University Osteoarthritis Index (WOMAC) as a full scale, it consists of pain scale, function scale, and stiffness scale. It is used to measure pain, function, and stiffness in patients with Osteoarthritis (OA) of the knee. 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. | Mean | Standard Deviation | Score |
| ||||||||||||||
| 36 Items Short Form Survey Instrument (SF-36v) Mental Scale | The Rand Short Form-36 (SF-36). It has Physical Health and Mental Health components. Mental Health component consisted of 4 scales; they are: 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. The total score ranged from 0 -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. | Mean | Standard Deviation | score |
| ||||||||||||||
| SF-36v Physical Scale | The Rand Short Form-36 (SF-36). We used Physical Health component for self reporting of general physical health.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 physical health. Lower scores correspond to worse physical health status, higher scores correspond to better physical health status. | Mean | Standard Deviation | score |
| ||||||||||||||
| Stair Total (climb, descend) | Total amount of stairs climbed and descended for three minutes. Subjects climbed four steps up and descended four steps down. | Mean | Standard Deviation | stairs |
| ||||||||||||||
| Married | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Change in Score | Between Base-line and 24 weeks |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Change in score | Between Base-line and 24 weeks |
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| 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. | 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 | Posted | Mean | 95% Confidence Interval | Change in Score | Between Base-line and 24 weeks |
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| Secondary | Walking Distance | Average distance walked in six minutes. The average change in distance walked (meters) 24 weeks post-baseline was measured. | 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. | Posted | Mean | 95% Confidence Interval | Change in Distance (m) | Between Base-line and 24 weeks |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Change in Steps | Between Base-line and 24 Weeks |
|
24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 28 | 6 | 28 | ||
| EG001 | 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. | 0 | 27 | 3 | 27 | ||
| EG002 | 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. | 0 | 30 | 7 | 30 | ||
| EG003 | Usual Care | Usual Care and non-specific health information (C). No intervention. | 0 | 25 | 6 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Two subjects experienced severe knee pain from the study and decided to terminate their participation after being reviewed by the PI. |
| |
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Some participants experienced A. Fib unrelated to the study and terminated their participation. |
| |
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Some participants experienced Chronic Obstructive Pulmonary Disease (COPD) unrelated to the study and terminated their participation. |
| |
| Chest Pain | General disorders | Systematic Assessment | Some participants experienced chest pain unrelated to the study and terminated their participation. |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Some participants developed pneumonia unrelated to the study and terminated their participation. |
| |
| CAD | Cardiac disorders | Systematic Assessment | Some participants developed Coronary Artery Disease unrelated to the study and terminated their participation. |
| |
| Brain Abscess | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Some participants developed a brain abscess unrelated to the study and terminated their participation. |
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| Confusion | Psychiatric disorders | Systematic Assessment | Some participants developed confusion unrelated to the study and terminated their participation. |
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| Cholecystitis | Gastrointestinal disorders | Systematic Assessment | Some participants developed cholecystitis unrelated to the study and terminated their participation. |
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| Moved | Social circumstances | Systematic Assessment | Some participants moved away from the local area and decided to terminate their participation. |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Some patients developed colon cancer unrelated to the study and decided to terminate their participation. |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment | Some patients developed diverticulitis unrelated to the study and decided to terminate their participation. |
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| Allergy | Immune system disorders | Systematic Assessment | Some participants developed an allergy unrelated to the study and decided to terminate their participation. |
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| Not Interested | Social circumstances | Systematic Assessment | Some participants decided they were not interested in the study anymore and terminated their participation. |
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Due to the small number of females, the results may not be generalizable to females. Limitations include requirement of having good upper body strength, shoulder range, hand eye coordination, and an investment of purchasing poles of $30 per pair.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elly Budiman-Mak, MS MPH MD | Edward Hines, Jr. VA Hospital | 708-202-2414 | elly.mak@va.gov |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D009765 | Obesity |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D009043 | Motor Activity |
| D000377 | Agnosia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D001519 | Behavior |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001836 | Body Weight Changes |
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| Male |
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| Non-white |
|
| Not-Married |
|
Covariates entered into the model were BMI and WOMAC function |
| 0.0535 |
| Mean Difference (Final Values) |
| -5.174 |
| 2-Sided |
| 95 |
| -10.43 |
| 0.079 |
| No |
| Superiority or Other |
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.
| OG002 | 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. |
| OG003 | Usual Care | Usual Care and non-specific health information (C). No intervention. |
|
|
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| 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. |
| OG002 | 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. |
| OG003 | Usual Care | Usual Care and non-specific health information (C). No intervention. |
|
|
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.
| OG003 | Usual Care | Usual Care and non-specific health information (C). No intervention. |
|
|
|
| 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. |
| OG003 | Usual Care | Usual Care and non-specific health information (C). No intervention. |
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