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This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital.
BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. This exercise was newly introduced to the Physiotherapy Department of Haven of Hope Hospital in March, 2020 and not a routine common training in Hospital Authority. However, currently the "BFR-device" is in its 3rd generation. Under the guidance of a certified physiotherapist, a "low load intensity" can be used for resistance training to build up muscle mass and strength by applying the device over the thigh to partially limit the blood flow to the distal limb.
BFR-RE is well studied in athletes, elderlies and patients for rehabilitation after orthopaedics surgeries. A large amount of literature reveals BFR-RE with "low load intensity" shows comparable increase of muscle mass as "high load intensity" resistance training and more increase of muscle strength than those only undergoing "low load intensity" resistance training.
The objective of this study is to investigate the additional effects of 2-week BFR-RE in patients with COPDAE on top of the conventional in-patient rehabilitation training. The primary outcome is effect on localized muscle strength. The secondary outcomes include mobility function, systemic muscle strength as reflected by handgrip strength(HGS), health related quality of life, unplanned readmission to acute hospital rate within 1 month for COPDAE.
Chronic obstructive pulmonary disease (COPD) is a prevalent disease around the world particularly in developed countries. COPD often has frequent admissions for acute exacerbation which increase the risks of mortality. Muscular dysfunction is one of extra-pulmonary morbidity of COPD.
Reduced muscle strength is associated with increased mortality in moderate to severe COPD. However, at least 70% of 1-repetition maximum (1-RM) of weight is needed to achieve muscle growth in resistance training. This might not be feasible particularly to the patients admitted for COPD acute exacerbation (COPDAE).
Blood flow restriction resistance training (BFR-RE), Kaatsu training, was developed by Dr. Yoshiaki Sato more than 40 years ago. The basic physiological mechanism of BFR-RE to increase muscle mass and strength is by metabolite accumulation, e.g. lactate. The metabolites lead to increase of serum growth hormone (GH) which promotes the collagen synthesis for tissue repair and recovery. The surge of GH leads to release of insulin-like growth factor (IGF-1) which is a protein related to muscle growth. IGF-1 contributes the muscle gain, which is a muscular anabolic process, by enhancing satellite cell proliferation.
Concerning growth of muscle mass, BFR-RE leads to a comparable increase when compared to high load resistance exercise (HL-RE). However, concerning increase of muscle strength, BFR-RE is less effective in gain than that in HL- RE but more effective than that in low load resistance exercise (LL-RE) alone. Therefore, BFR-RE can be considered when HL- RE is not advisable. (e.g. frail elderly, post-operative rehabilitation, etc.) BFR-RE is well studied among healthy adult, elderly and musculoskeletal rehabilitation patients, but not in COPDAE patients.
Standardized isotonic knee extension resistance training on alternate day with a load of 15-30% of 1-Repetition Maximum (1-RM) with "BFR-device" will be compared with the control arm having same set of exercise training without the device in COPDAE patient during 2-week of inpatient stay. Referred to previous study with 30% drop out rate estimation, 24 patients for each arm will be needed. Study period will be set to be 9 months or until expected recruitment achieved.
Though there no adverse risk responses were reported in published randomized controlled trials in clinical populations in the literature, there are some expected transient perceptual type responses, e.g. dizziness, limb numbness, perceived exertion, delayed onset muscle soreness. There are no significant risks of complications if BFR-RE is prescribed by certified trainers who have knowledge of appropriate protocols and contraindications to the use of occlusive stimuli.
The effect on muscle strength in COPDAE inpatient, which is not well studied in the literatures, will be the primary outcome of this study. The effect on mobility functions, systemic muscle strength, health related quality of life, unplanned readmission rate within 1 month of discharge for COPDAE, acceptability and feasibility of the BFR-RE will be evaluated as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BFR-RE intervention group | Experimental | The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
|
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| Control group | No Intervention | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction resistance exercise | Device | Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks | To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length. Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg. | baseline and 3 weeks (after 10-12 sessions of training) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks | SPPB is the sum of the points from the following 3 measures, high the point, better performance
Minimum score=0 Maximum score=12(best performance) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| chung wai LAU, MBBS | Hospital Authority, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haven of Hope Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19204579 | Background | American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670. | |
| Background | Brandner, C. R., May, A. K., Clarkson, M. J., & Warmington, S. A. Reported Side-effects and Safety Considerations for the Use of Blood Flow Restriction During Exercise in Practice and Research. Techniques in Orthopaedics. 2018; 33(2), 114-121. | ||
| 30306467 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Flow Restriction Resistance Exercise Intervention Group | The participants will have the standardised 2 week resistance training with "Blood flow restriction-device" with details as follows:
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension |
| FG001 | Control Group | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BFR-RE Intervention Group | The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension |
| 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 | Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks | To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length. Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg. | Posted | Median | Inter-Quartile Range | kgf | baseline and 3 weeks (after 10-12 sessions of training) |
|
1month
acute exacerbation or hospital acquired infections
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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 | BFR-RE Intervention Group | The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
Blood flow restriction resistance exercise: Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD acute exacerbation or hospital acquired infections | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | COPD acute exacerbation or hospital acquired infections |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lau Chung Wai | Haven of Hope hospital, Hospital Authority | 27038888 | lcw431@ha.org.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 8, 2020 | Dec 18, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Participants are randomized into one of the two treatment groups by drawing enclosed envelops which contain the random allocation of participants to intervention group (training with "BFR-device" and control group (training without the device). The envelopes are opened after inclusion for the individual participant only.
Stratification of participants into two groups by maximum voluntary isometric contraction (MVIC) at baseline before randomization will be done. The cutoff for the stratification will be determined from the data in the recent service.
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The Assessor for the primary outcome (maximum voluntary isometric contraction, MVIC) of knee extension, functional outcomes(6-minute walk test, Short Physical Performance Battery), will be blinded to the allocated study group.
| baseline and 3 weeks (after 10-12 sessions of training) |
| Change of Hand Grip Strength in 3 Weeks | a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand | baseline and 3 weeks (after 10-12 sessions of training) |
| Change of Health Related Quality of Life in 3 Weeks | Self-administered Chinese version of Chronic obstructive pulmonary disease(COPD) assessment test (CAT) It contains 8 questions and 6 points each (0 to 5). Higher score means worse health status. The Minimal clinical important difference of CAT score was 2 to 3. Minimum score=0 Maximum score=40 (worst health status) | baseline and 3 weeks (after 10-12 sessions of training) |
| Average Pain Score of Each Training | Visual analog scale (0-10) for before, immediate and 5-minute post exercise. least pain=0 ; most severe pain=10 | pain score before, immediate and 5-minute post exercise; |
| Reasons of Drop-out of Blood Flow Restriction Resistance Exercise | Examination the reasons of drop-out in those discontinuing the training | baseline to 3 weeks (after 10-12 sessions of training) |
| Feasibility of BFR Exercise | Examination of drop-out rate | baseline and 3 weeks (after 10-12 sessions of training) |
| Unplanned Readmission Rate on 1 Month Post Discharge | Unplanned readmission rate within 1 month of discharge for Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE) | 1 month after the discharge of patients in the study |
| 6-minute Walk Test Distance Gain | the distance can achieved in 6-minute walk test | baseline and 3 weeks (after 10-12 sessions of training) |
| Acceptability of Blood Flow Restriction Resistance Exercise | Measure the patient's acceptance by a 5-point categorical scale after the whole program. 1=very dislike, 2=dislike,3=no comment, 4= like, 5=very like Lowest score=1 Highest score=5(Higher score means better acceptance) | Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training) |
| Background |
| Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1. |
| 28987643 | Background | Cook SB, LaRoche DP, Villa MR, Barile H, Manini TM. Blood flow restricted resistance training in older adults at risk of mobility limitations. Exp Gerontol. 2017 Dec 1;99:138-145. doi: 10.1016/j.exger.2017.10.004. Epub 2017 Oct 5. |
| 28259850 | Background | Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4. |
| 19305199 | Background | Manini TM, Clark BC. Blood flow restricted exercise and skeletal muscle health. Exerc Sport Sci Rev. 2009 Apr;37(2):78-85. doi: 10.1097/JES.0b013e31819c2e5c. |
| Background | Sato, Y. The history and future of KAATSU Training. International Journal of KAATSU Training Research. 2005; 1(1): 1-5. |
| 17090575 | Background | Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7. |
| 14755493 | Background | Van't Hul A, Harlaar J, Gosselink R, Hollander P, Postmus P, Kwakkel G. Quadriceps muscle endurance in patients with chronic obstructive pulmonary disease. Muscle Nerve. 2004 Feb;29(2):267-74. doi: 10.1002/mus.10552. |
| 7191799 | Background | Kroemer KH, Marras WS. Towards an objective assessment of the "maximal voluntary contraction" component in routine muscle strength measurements. Eur J Appl Physiol Occup Physiol. 1980;45(1):1-9. doi: 10.1007/BF00421195. |
| 20724932 | Background | Robles PG, Mathur S, Janaudis-Fereira T, Dolmage TE, Goldstein RS, Brooks D. Measurement of peripheral muscle strength in individuals with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):11-24. doi: 10.1097/HCR.0b013e3181ebf302. |
| 26664110 | Background | Bernabeu-Mora R, Medina-Mirapeix F, Llamazares-Herran E, Garcia-Guillamon G, Gimenez-Gimenez LM, Sanchez-Nieto JM. The Short Physical Performance Battery is a discriminative tool for identifying patients with COPD at risk of disability. Int J Chron Obstruct Pulmon Dis. 2015 Dec 3;10:2619-26. doi: 10.2147/COPD.S94377. eCollection 2015. |
| 24075334 | Background | Hicks RW, Denholm B. Implementing AORN recommended practices for care of patients undergoing pneumatic tourniquet-assisted procedures. AORN J. 2013 Oct;98(4):383-93; quiz 394-6. doi: 10.1016/j.aorn.2013.08.004. |
| 27428935 | Background | Kearon C, Ageno W, Cannegieter SC, Cosmi B, Geersing GJ, Kyrle PA; Subcommittees on Control of Anticoagulation, and Predictive and Diagnostic Variables in Thrombotic Disease. Categorization of patients as having provoked or unprovoked venous thromboembolism: guidance from the SSC of ISTH. J Thromb Haemost. 2016 Jul;14(7):1480-3. doi: 10.1111/jth.13336. Epub 2016 Jun 7. No abstract available. |
| 28848339 | Background | Jeong M, Kang HK, Song P, Park HK, Jung H, Lee SS, Koo HK. Hand grip strength in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2017 Aug 9;12:2385-2390. doi: 10.2147/COPD.S140915. eCollection 2017. |
| 29200647 | Background | Kanada Y, Sakurai H, Sugiura Y, Arai T, Koyama S, Tanabe S. Estimation of 1RM for knee extension based on the maximal isometric muscle strength and body composition. J Phys Ther Sci. 2017 Nov;29(11):2013-2017. doi: 10.1589/jpts.29.2013. Epub 2017 Nov 24. |
| 21922259 | Background | Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16. |
| 29287067 | Background | van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017. |
| 31156448 | Background | Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019. |
| Background | Takeichi N, Ishizaka S, Nishiyama M, et al. Prediction of 1 repetition maximum strength from isometric strength using Hand-Held Dynamometer for the knee extenser. Gen Rehabil, 2012; 40: 1005-1009. |
| 28465129 | Background | Yu R, Ong S, Cheung O, Leung J, Woo J. Reference Values of Grip Strength, Prevalence of Low Grip Strength, and Factors Affecting Grip Strength Values in Chinese Adults. J Am Med Dir Assoc. 2017 Jun 1;18(6):551.e9-551.e16. doi: 10.1016/j.jamda.2017.03.006. Epub 2017 Apr 29. |
| 37976375 | Derived | Lau CW, Leung SY, Wah SH, Yip CW, Wong WY, Chan KS. Effect on muscle strength after blood flow restriction resistance exercise in early in-patient rehabilitation of post-chronic obstructive pulmonary disease acute exacerbation, a single blinded, randomized controlled study. Chron Respir Dis. 2023 Jan-Dec;20:14799731231211845. doi: 10.1177/14799731231211845. |
| BG001 | Control Group | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body mass index, obstruction, dyspnea, exercise (BODE) index | The BODE index scores range from 0 to 10, higher the score, higher the mortality rate at 52 months. The index is the sum of the scores from the 4 components:
| Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Control Group | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
|
|
| Secondary | Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks | SPPB is the sum of the points from the following 3 measures, high the point, better performance
Minimum score=0 Maximum score=12(best performance) | Posted | Median | Inter-Quartile Range | score on a scale | baseline and 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Change of Hand Grip Strength in 3 Weeks | a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand | Posted | Median | Inter-Quartile Range | kg | baseline and 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Change of Health Related Quality of Life in 3 Weeks | Self-administered Chinese version of Chronic obstructive pulmonary disease(COPD) assessment test (CAT) It contains 8 questions and 6 points each (0 to 5). Higher score means worse health status. The Minimal clinical important difference of CAT score was 2 to 3. Minimum score=0 Maximum score=40 (worst health status) | Posted | Median | Inter-Quartile Range | units on a scale | baseline and 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Average Pain Score of Each Training | Visual analog scale (0-10) for before, immediate and 5-minute post exercise. least pain=0 ; most severe pain=10 | Posted | Median | Inter-Quartile Range | score on a scale | pain score before, immediate and 5-minute post exercise; |
|
|
|
| Secondary | Reasons of Drop-out of Blood Flow Restriction Resistance Exercise | Examination the reasons of drop-out in those discontinuing the training | Posted | Count of Participants | Participants | baseline to 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Feasibility of BFR Exercise | Examination of drop-out rate | Posted | Count of Participants | Participants | baseline and 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Unplanned Readmission Rate on 1 Month Post Discharge | Unplanned readmission rate within 1 month of discharge for Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE) | Posted | Count of Participants | Participants | 1 month after the discharge of patients in the study |
|
|
|
| Secondary | 6-minute Walk Test Distance Gain | the distance can achieved in 6-minute walk test | Posted | Median | Inter-Quartile Range | m | baseline and 3 weeks (after 10-12 sessions of training) |
|
|
|
| Secondary | Acceptability of Blood Flow Restriction Resistance Exercise | Measure the patient's acceptance by a 5-point categorical scale after the whole program. 1=very dislike, 2=dislike,3=no comment, 4= like, 5=very like Lowest score=1 Highest score=5(Higher score means better acceptance) | Posted | Count of Participants | Participants | Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training) |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 11 |
| 20 |
| EG001 | Control Group | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". | 0 | 25 | 0 | 25 | 4 | 25 |
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| Others | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | accidental fall with knee injury walking limited by low back pain |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment | Insomnia |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 5 mins after training |
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| Due to failure to complete training |
|
| No admission |
|