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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-01422 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00018354 | Other Identifier | OHSU Knight Cancer Institute | |
| R01CA222605 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
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The GET FIT Prostate trial (Group Exercise Training for Fall prevention and functional Improvements during and after Treatment for Prostate cancer) is a single-blind, parallel group, randomized controlled trial comparing - 1) tai ji quan (functional balance) and 2) strength training (functional strength) against each other and vs. 3) a stretching control (functional mobility) - over a 6-mos. supervised intervention and 6-mos. follow-up. Two million prostate cancer survivors are alive in the U.S. and nearly half (45%) will receive androgen deprivation therapy (ADT) to reduce tumor androgen exposure and slow down cancer progression. While beneficial for cancer survival, significant treatment-induced side effects from ADT may lead to serious health consequences including falls, frailty, and dysfunction that contribute to morbidity and mortality
PRIMARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training in reducing the incidence of falls in prostate cancer survivors on antiandrogen therapy (ADT).
SECONDARY OBJECTIVE:
I. To determine and compare the efficacy of tai ji quan training and strength training to reduce frailty and dysfunction in prostate cancer survivors on ADT.
TERTIARY OBJECTIVE:
I. To determine how well the benefits of tai ji quan and strength interventions persist over a 6-month period.
EXPLORATORY OBJECTIVE:
I. To explore the patterns and predictors of types of men (including host and treatment factors) who benefit most from tai ji quan and strength training.
OUTLINE:
The study is a 3-group, single-blind, parallel design randomized controlled trial in prostate cancer survivors treated with ADT. Participants in each study group will attend supervised 1-hr classes, 3 days a week for 6 months.
ARM 1: Tai ji quan, an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements, specifically designed to challenge limits of stability and train gait patterns, as reflected in movements such as upright trunk positioning, displacement of body's center of mass over the weight-bearing leg, and step initiation, locomotion, and termination.
ARM 2: Strength training. Participants wear a weighted vest while performing exercises using functional movement patterns that challenge balance by using muscle groups and movement involved in everyday activities (chair rises, 90°squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups).
ARM 3: Stretching control. Participants in the control group will attend a supervised flexibility program of the same total weekly duration as the experimental arms (e.g., 3, 60-min sessions per week). Control participants will perform a series of whole body stretching exercises, according to the ACSM guidelines for flexibility training, with a focus on developing and maintaining a healthy back.
Six Month Follow-Up: Participants will be followed for an additional 6 months after the 6-month supervised intervention stops to track falls (using same monthly report used during intervention phase). Exercise questionnaires to track participation in home or community exercise programs and will be collected at the 9- and 12-month time periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength Training | Experimental | Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups). Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session. |
|
| Stretching Control | Active Comparator | Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session. |
|
| Tai Ji Quan Training | Experimental | An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training | Other | Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls | Prospective assessment of falls will be done by collecting monthly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard. | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Frailty Score | Frailty will be measured using the components of the Frailty Phenotype, which consist of measures of lean body mass, fatigue, physical activity, walk speed, and muscle strength, listed as additional outcomes below. Each component of frailty is assessed using measures that will capture frailty criteria in the prostate cancer survivor population using appropriate cutoff scores indicating that a component meets a particular criterion. A total frailty score was calculated for each patient at each timepoint defined as a count of the number of frailty components met. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Winters-Stone, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39606939 | Derived | Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518. | |
| 34742325 | Derived | Winters-Stone KM, Li F, Horak F, Dieckmann N, Hung A, Amling C, Beer TM. Protocol for GET FIT Prostate: a randomized, controlled trial of group exercise training for fall prevention and functional improvements during and after treatment for prostate cancer. Trials. 2021 Nov 6;22(1):775. doi: 10.1186/s13063-021-05687-7. |
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All individual quantitative participant data collected during the trial, after deidentification.
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Beginning 3 months following final publication
Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.
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284 men met eligibility criteria and were randomized to receive one of three treatment arms as specified per protocol.
Community-dwelling prostate cancer survivors were recruited between February 2019 and September 2022. The first participant was enrolled on the 5th of February 2019 and the last participant was enrolled on the 19th of September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Strength Training | Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups). Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session. Resistance Training: Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session. |
| FG001 | Stretching Control | Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session. Stretching: Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session |
| FG002 | Tai Ji Quan Training | An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. Tai Chi: Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Strength Training | Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups). Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session. Resistance Training: Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Falls | Prospective assessment of falls will be done by collecting monthly reports returned by postal and/or electronic mail. A fall is defined as unintentionally coming to rest on the ground or at some other lower level, not as a result of a major intrinsic event (e.g., stroke or syncope) or overwhelming hazard. | Posted | Mean | 95% Confidence Interval | Average fall count per 6 months | Baseline up to 6 months |
|
Up to 1 year.
An Adverse Event survey was created by the study team to be administered monthly during the participants' year-long participation in the study.
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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 | Strength Training | Participants wear a weighted vest while performing exercises using functional movement patterns used in everyday activities (chair rises, 90° squats, side-to-side squats, toe raises, lunges (forward, lateral, backward, walking), multi-directional step ups). Participants attend supervised, group-based moderate-intensity strength training program remotely 3 times per week for 60 minutes per session. Resistance Training: Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kerri Winters-Stone | Oregon Health & Science University | 503-494-0813 | wintersk@ohsu.edu |
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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 | Aug 10, 2023 | Mar 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2023 | Mar 17, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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3-group, single-blind, parallel design randomized controlled trial
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Outcomes assessors will be masked to the participants assigned study arm. Participants will not be formally masked from knowing whether or not they are assigned to an experimental or control group, but every effort will be made not to overemphasize expected outcomes.
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| Stretching | Other | Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session |
|
| Tai Chi | Other | Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. |
|
| Baseline up to 12 months |
| Lean Body Mass | Lean body mass will be measured by bioelectric impedance analysis (in kg). Higher values indicate higher lean body mass. | Baseline up to 12 months |
| Fatigue-general | Fatigue will be measured using the Short Form (SF)-36 Vitality scale. The scale ranges from 0-100 with lower scores indicating higher fatigue (i.e., less vitality). | Baseline up to 12 months |
| Fatigue-cancer | Fatigue will also be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The questionnaire includes 13 items rated from "not at all" to "very much" over the past 7 days, and possible scores from 0 to 52. Lower scores indicate more fatigue, while higher scores indicate less severe fatigue. | Baseline up to 12 months |
| Physical Activity | Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report moderate-to-vigorous physical activity (MVPA). Lower scores indicate less MVPA and higher scores indicate more MVPA. | Baseline up to 12 months |
| Walk Speed | Walk speed will be measured by the 3-meter Timed Up and Go, a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. | Baseline up to 12 months |
| Muscle Strength | Muscle strength will be measured by timed chair stand test (seconds required to rise from chair 5 times). The larger the time, the longer it took them to complete 5 chair stands. | Baseline up to 12 months |
| Change in Functional Mobility | Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 meters (m), turn around a cone and return and sit in the chair. Larger times means they were slower, and shorter times mean they were faster. | Baseline up to 12 months |
| Change in Functional Balance | Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Participants will perform a standard 30-second postural sway test to measure the velocity (meters per second [m/s]) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. Lower sway velocity (m/s) indicates better postural stability. | Baseline up to 12 months |
| Change in Perceived Physical Function | Perceived physical function will be measured by self-report using the physical function subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3, App. I). Scores on the subscale range from 0-100 where higher scores indicate better physical functioning. | Baseline up to 12 months |
| Flexibility | Flexibility will be measured using the chair sit and reach. While seated on the edge of a chair, participants bend from the hip and reach toward or past the toes. The toes represent 0, so a reach short of the toes is recorded in negative inches, and a reach past the toes is recorded in positive inches. Higher negative values indicate greater flexibility. | Baseline up to 12 months |
| 34741653 | Derived | Winters-Stone KM, Boisvert C, Li F, Lyons KS, Beer TM, Mitri Z, Meyers G, Eckstrom E, Campbell KL. Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise? Support Care Cancer. 2022 Mar;30(3):1903-1906. doi: 10.1007/s00520-021-06669-w. Epub 2021 Nov 6. |
| BG001 | Stretching Control | Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session. Stretching: Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session |
| BG002 | Tai Ji Quan Training | An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. Tai Chi: Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Stretching Control | Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session. Stretching: Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session |
| OG002 | Tai Ji Quan Training | An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. Tai Chi: Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. |
|
|
| Secondary | Change in Total Frailty Score | Frailty will be measured using the components of the Frailty Phenotype, which consist of measures of lean body mass, fatigue, physical activity, walk speed, and muscle strength, listed as additional outcomes below. Each component of frailty is assessed using measures that will capture frailty criteria in the prostate cancer survivor population using appropriate cutoff scores indicating that a component meets a particular criterion. A total frailty score was calculated for each patient at each timepoint defined as a count of the number of frailty components met. | Posted | Number | 95% Confidence Interval | Incidence rate ratio | Baseline up to 12 months |
|
|
|
| Secondary | Lean Body Mass | Lean body mass will be measured by bioelectric impedance analysis (in kg). Higher values indicate higher lean body mass. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Fatigue-general | Fatigue will be measured using the Short Form (SF)-36 Vitality scale. The scale ranges from 0-100 with lower scores indicating higher fatigue (i.e., less vitality). | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Fatigue-cancer | Fatigue will also be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). The questionnaire includes 13 items rated from "not at all" to "very much" over the past 7 days, and possible scores from 0 to 52. Lower scores indicate more fatigue, while higher scores indicate less severe fatigue. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Physical Activity | Physical activity will be measured by physical activity-related energy expenditure (kcals/week) calculated from self-report moderate-to-vigorous physical activity (MVPA). Lower scores indicate less MVPA and higher scores indicate more MVPA. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Walk Speed | Walk speed will be measured by the 3-meter Timed Up and Go, a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Muscle Strength | Muscle strength will be measured by timed chair stand test (seconds required to rise from chair 5 times). The larger the time, the longer it took them to complete 5 chair stands. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Change in Functional Mobility | Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 meters (m), turn around a cone and return and sit in the chair. Larger times means they were slower, and shorter times mean they were faster. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Change in Functional Balance | Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Participants will perform a standard 30-second postural sway test to measure the velocity (meters per second [m/s]) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk. Lower sway velocity (m/s) indicates better postural stability. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Change in Perceived Physical Function | Perceived physical function will be measured by self-report using the physical function subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; version 3, App. I). Scores on the subscale range from 0-100 where higher scores indicate better physical functioning. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| Secondary | Flexibility | Flexibility will be measured using the chair sit and reach. While seated on the edge of a chair, participants bend from the hip and reach toward or past the toes. The toes represent 0, so a reach short of the toes is recorded in negative inches, and a reach past the toes is recorded in positive inches. Higher negative values indicate greater flexibility. | Posted | Mean | 95% Confidence Interval | Score on a scale per 6 months | Baseline up to 12 months |
|
|
|
| 2 |
| 97 |
| 1 |
| 97 |
| 0 |
| 97 |
| EG001 | Stretching Control | Participants attend a supervised flexibility program where they will perform a series of whole body stretching exercises with a focus on developing and maintaining a healthy back. Participants attend a supervised, group-based supervised flexibility program remotely 3 times per week for 60 minutes per session. Stretching: Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session | 4 | 92 | 0 | 92 | 0 | 92 |
| EG002 | Tai Ji Quan Training | An integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements. Participants attend a supervised, group-based tai ji quan program remotely where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. Tai Chi: Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session. | 1 | 95 | 3 | 95 | 0 | 95 |
| Lung nodule | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| New immunotherapy treatment | General disorders | Systematic Assessment |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026241 | Exercise Movement Techniques |
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| 6mo-12mo |
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