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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-04622 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21AG078258 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.
PRIMARY OBJECTIVES:
I. Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance training randomized trial with 70 older cancer survivors.
II. Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with the intervention participants.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.
ARM 2: Patients receive educational materials at baseline.
After completion of study intervention, patients are followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (nutritional counseling, resistance training) | Experimental | Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. |
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| Arm 2 (educational materials) | Active Comparator | Patients receive educational materials at baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Participate in online resistance training sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical Function at End-of-intervention | Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention. | end-of-intervention, at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions | Percentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction. | end-of-intervention, at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Krok-Schoen, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Nutritional Counseling, Resistance Training) | Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. Exercise Intervention: Participate in online resistance training sessions Informational Intervention: Given educational materials Nutritional Assessment: Participate in online nutritional counseling Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2024 |
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| Informational Intervention | Other | Given educational materials |
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| Nutritional Assessment | Other | Participate in online nutritional counseling |
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| Physical Performance Testing | Other | Ancillary studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Study Accrual Rate |
Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures. |
| assessed during the 12 month recruitment period |
| Study Retention Rate | calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported. | End-of-study, up to 3 months |
| Study Adherence Rate | Participants were determined to be adherent if they attend >= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported. | end-of-intervention, at 12 weeks |
| Grip Strength | Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs. | end-of-intervention, at 12 weeks |
| Dietary Quality | Dietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score. | end-of-intervention, at 12 weeks |
| Percentage of Participants Who Completed Resistance Exercises | Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted "yes" to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention. | end-of-intervention, at 12 weeks |
| Health-related Quality of Life (HRQoL) | RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported. | end-of-intervention, at 12 weeks |
| Self-efficacy | Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident. | end-of-intervention, at 12 weeks |
| Technology Competency | The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy. | end-of-intervention, at 12 weeks |
| Anthropometry Body Weight in Kilograms | At end-of-intervention, participant's body weight was assessed in kilograms. | end-of-intervention, at 12 weeks |
| Anthropometry Height in Inches | At end-of-intervention, participants' height was assessed using height in centimeters. | end-of-intervention, at 12 weeks |
| Anthropometry Measuring Waist Circumference in Centimeters | At end-of-intervention, participants' waist circumference was assessed in centimeters. | end-of-intervention, at 12 weeks |
| FG001 | Arm 2 (Educational Materials) | Patients receive educational materials at baseline. Informational Intervention: Given educational materials Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Nutritional Counseling, Resistance Training) | Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. Exercise Intervention: Participate in online resistance training sessions Informational Intervention: Given educational materials Nutritional Assessment: Participate in online nutritional counseling Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG001 | Arm 2 (Educational Materials) | Patients receive educational materials at baseline. Informational Intervention: Given educational materials Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Short Physical Performance Battery | The physical performance assessment, Short Physical Performance Battery (SPPB), will measure physical function at baseline, end-of-study, and follow-up. The SPPB includes three lower extremity physical performance measures (standing balance, five consecutive chair rises, 4-meter gait walk at usual pace), all summed, to assess lower extremity strength. Summary scores range from 0 to 12, with higher scores denoting higher physical function. | Mean | Full Range | units on a scale |
| ||||||||||||||||
| Grip strength | Handgrip strength will be measured at baseline, end-of-study, and follow-up in both hands using a hydraulic grip strength dynamometer (Jamar Model 7498). Three trials with brief pauses will be conducted for each hand and the mean score of the six trials will be used as the mean handgrip score (in kgs). | Mean | Standard Deviation | kg |
| ||||||||||||||||
| Diet History Questionnaire III | Dietary quality was assessed at baseline and end-of-study by the National Cancer Institute's Diet History Questionnaire III (DHQIII).The DHQIII assesses Healthy Eating Index-2015 (HEI-2015) total and individual component scores (e.g., protein) and average daily nutrient intakes, according to the dietary guidelines. Scores can range from 0-100, with higher scores denoting higher dietary quality. | Mean | Inter-Quartile Range | units on a scale |
| ||||||||||||||||
| Godin leisure time exercise | Self-reported resistance exercise, vigorous, moderate, and mild exercise was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. Scores on the Godin can range from 0-14 units (insufficiently active), 14-23 units (moderately active), or 24 or more units (active). There is no scoring limit. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| RAND-36 | RAND-36 Health Status Measure is comprised of 8 subscales assessing multiple aspects of HRQoL. Physical and mental component summaries are created. All scores range from 0-100, with 100 as the highest. Changes of ≥5 points on the component scores are considered clinically relevant | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Self-efficacy for diet and exercise | Baseline and end-of-study self-efficacy for diet and resistance training were measured by: "How sure are you that you could do exercises to make your body stronger for 15 minutes, 3 days a week?" and "How sure are you that you could improve your diet?" A 10-point Likert response scale, ranging from a score of 1 (completely uncertain) to 10 (completely certain), was used. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Self-regulation for diet and exercise | Baseline and end-of-study self-regulation for diet and exercise will be measured by the 12-item Dietary Self-Regulation Scale and the 12-item Exercise Self-Regulation Scale. Questions are on a 5-item Likert scale 1-5, never to strongly agree. Each self-regulation scale sums the scores for each item so the scores can range from 12-60, with higher scores denoting higher self-regulation. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| eHealth Literacy Scale | The 8-item eHealth Literacy Scale (eHEALS) measured knowledge, comfort, and perceived skills of engaging in eHealth at baseline and end-of-study. A 5-point Likert scale (strongly disagree to strongly agree) was used. The total summed scores range from 8-40, with higher scores indicating higher self-perceived ehealth literacy. | Mean | Standard Deviation | units on a scale |
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| 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 | Physical Function at End-of-intervention | Measured by the Short Physical Performance Battery (SPPB) score. The SPPB score is a continuous variable, collected as the total score ranging from 0-12, higher scores denote higher physical function. Values reported are at the end-of-intervention. | Posted | Mean | Standard Deviation | score on a scale | end-of-intervention, at 12 weeks |
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| Secondary | Satisfaction of the Delivery Method and Information Provided by Nutrition and Exercise Counseling Sessions | Percentage of participant satisfaction ("satisfied" and "very satisfied") measured by a 5-item Likert-scale questionnaire. Scores range from 1-5, with 5 being the highest score of satisfaction. | Posted | Mean | Full Range | score on a scale | end-of-intervention, at 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Study Accrual Rate | Will be calculated by dividing the number of potential participants that passed screening by the total number of participants started in the study after appropriate informed consent procedures. | The number of participants analyzed represents all potential older cancer survivors (OCS) contacted and assessed for eligibility for participation in the study. | Posted | Number | percentage of participants | assessed during the 12 month recruitment period |
|
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| Secondary | Study Retention Rate | calculated by dividing the total number of participants initiated by total number of participants in the study. Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal for this trial will be achieved. Overall retention rates and associated 95% confidence intervals will be reported. | Posted | Count of Participants | Participants | End-of-study, up to 3 months |
| ||||||||||||||||||||||||||||||||
| Secondary | Study Adherence Rate | Participants were determined to be adherent if they attend >= 80% of the online intervention sessions. Overall adherence rates and associated 95% confidence intervals were reported. | Percentage of Participants who Attended >= 80% of the Intervention Sessions | Posted | Number | percentage of participants | end-of-intervention, at 12 weeks |
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| Secondary | Grip Strength | Handgrip strength (absolute value at the end of the intervention) was measured in both hands using a hydraulic grip strength dynamometer. This is measured in kgs. | Posted | Mean | Standard Deviation | kgs | end-of-intervention, at 12 weeks |
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| Secondary | Dietary Quality | Dietary quality was assessed by the National Cancer Institute's Diet History Questionnaire III using the Healthy Eating Index score ranging 0-100, with higher scores meaning higher diet quality. Absolute value at end-of-intervention was assessed using the Healthy Eating Index score. | Posted | Mean | 95% Confidence Interval | score on a scale | end-of-intervention, at 12 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Completed Resistance Exercises | Self-reported resistance exercise (% yes) was assessed using the revised version of The Godin-Shephard Leisure-Time Exercise Questionnaire modified to specifically capture self-reported resistance exercise participation. If a participant denoted "yes" to the question: did During a typical 7-Day period (a week), did you participate in resistance exercise for more than 15 minutes during your free time? Percentages denote the percentage of the study subjects who participated in resistance training at end of intervention. | Posted | Number | percentage of participants | end-of-intervention, at 12 weeks |
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| Secondary | Health-related Quality of Life (HRQoL) | RAND-36 Health Status Measure is comprised of 36 items which automatically create 8 subscales assessing multiple aspects of HRQoL. All scores range from 0-100, with 100 as the highest HRQoL. The main HRQoL subscale reported is the general health HRQoL subscale. Mean scores of general HRQoL for end-of-intervention are reported. | Posted | Mean | Standard Error | score on a scale | end-of-intervention, at 12 weeks |
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| Secondary | Self-efficacy | Self-efficacy was measured at the end of intervention via a 0-10 confidence scale rating the confidence of making exercise and diet changes in one's life, with 0 meaning not confident, 10 meaning very confident. | Posted | Mean | Standard Deviation | score on a scale | end-of-intervention, at 12 weeks |
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| Secondary | Technology Competency | The 8-item eHealth Literacy Scale measured knowledge, comfort, and perceived skills of engaging in eHealth at end-of-intervention. A 5-point Likert scale was used, with possible scores ranging from 8 to 40. Higher scores indicate higher ehealth literacy. | Posted | Mean | Full Range | score on a scale | end-of-intervention, at 12 weeks |
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| Secondary | Anthropometry Body Weight in Kilograms | At end-of-intervention, participant's body weight was assessed in kilograms. | Posted | Median | Inter-Quartile Range | kg | end-of-intervention, at 12 weeks |
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| Secondary | Anthropometry Height in Inches | At end-of-intervention, participants' height was assessed using height in centimeters. | Posted | Mean | Standard Deviation | cm | end-of-intervention, at 12 weeks |
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| Secondary | Anthropometry Measuring Waist Circumference in Centimeters | At end-of-intervention, participants' waist circumference was assessed in centimeters. | Posted | Median | Inter-Quartile Range | cm | end-of-intervention, at 12 weeks |
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Adverse events were collected at each of the participant's in-person data collection events (baseline, 12 weeks, and 24 weeks). Also participants could contact the study team at any time.
Not different than the definition from clinicaltrials.gov definitions.
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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 | Arm 1 (Nutritional Counseling, Resistance Training) | Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline. Exercise Intervention: Participate in online resistance training sessions Informational Intervention: Given educational materials Nutritional Assessment: Participate in online nutritional counseling Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 38 | 0 | 38 | 0 | 38 |
| EG001 | Arm 2 (Educational Materials) | Patients receive educational materials at baseline. Informational Intervention: Given educational materials Physical Performance Testing: Ancillary studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies | 0 | 37 | 0 | 37 | 0 | 37 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Krok-Schoen, Associate Professor | School of Health and Rehabilitation Sciences, College of Medicine, The Ohio State University | 8133686470 | Jessica.krok@osumc.edu |
| Oct 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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