Sample Research Methodology

Topic: The Effects of Blood Flow Restriction Therapy on Chronic Pain and Functional Mobility in Adults with Rheumatic Diseases

Methodology

Study design 

It’s a randomized controlled experiment that took place in that time frame (within six months). Before taking part in the research, each participant read and signed an informed consent form, and the project was given the green light by the local ethics council. All methods followed the updated 2008 Helsinki Declaration. Patients were divided into tertiles based on their 1-repetition maximum (RM) for the leg press exercise, and then randomly assigned to high-intensity (HI-RT), low-intensity (LI-RT), or low-intensity (LI-RT) with blood flow restriction (BFR) training (BFRT). We measured 1-repetition maximum (1-RM) leg press and knee extension, physical function (as measured by timed-stands [TST] and timed-up-and-go [TUG] tests), quadriceps cross-sectional area (CSA), and self-reported quality of life at pre- and post-training intervals of 12 weeks (as assessed by Short Form Health Survey [SF-36] and Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]). Adverse occurrences were tracked when they were reported by participants. Sample Research Methodology.

Participants

Seven people, all between the ages of 60 and 65 and all having a diagnosis of knee osteoarthritis under the American College of Rheumatology’s criteria, will take part in the research. Involvement in physical exercise training within the preceding year; cardiovascular diseases and musculoskeletal disturbances that prevented exercise participation; Kellgren-Lawrence radiographic grade 1 or 4; knee pain numeric visual scale (VAS) less than 1 or greater than 8; use of nonsteroidal anti-inflammatory drugs within the past three months; intra-articular infiltration with hyaluronic acid and corticosteroids infiltratio; and infiltratio of hyaluronic. Sample Research Methodology.

Participants with peripheral vascular disease, systolic blood pressure (SBP) greater than 160 mm Hg or less than 100 mm Hg, diastolic blood pressure (DBP) greater than 100 mm Hg, absolute contraindications to start exercising training, or other health problems that would preclude safe participation are not eligible to use tourniquets. Persons younger than 60 who show objective indicators of functional limits, do not engage in regular resistance exercise, and have knee OA are therefore eligible to enroll. Sample Research Methodology.

Resistance training programs

The RT was done at a gym inside the hospital. There were twice-weekly workouts supervised by a fitness trainer. Using standard strength training equipment, the RT programme included bilateral leg presses and knee extensions. The first week of training consisted of acclimating the individuals to their procedures, as detailed below. There were four sets of ten reps for HI-RT and four sets of fifteen reps for LI-RT, with HI-RT using 50% of 1-RM and LI-RT using 20% of 1-RM. Starting in the second week, both HI-RT and LI-RT raised their training intensity to 80% of their 1-repetition maximum (RM) and, beginning in the fifth week, both groupings raised the number of sets done for each activity from four to five. In order to provide partial blood flow restriction, BFRT trained with an air cuff placed at the inguinal fold (width 175 mm x length 920 mm – inflated to 70% of the pressure needed to provide complete blood flow restriction. Training intensity and load progression were identical to LI-RT. It’s important to note that the air cuff, and consequently the restriction of blood flow, remained in place the whole time, including during rest periods, and was only removed after the training sessions were over. All teams were given a minute of respite in between each set. Every four weeks, participants’ exercise loads were readjusted based on a new 1-RM assessment. There exists a more in-depth explanation of how to gradually increase training intensity and blood flow restriction. Compliance to the exercise regimen was tracked by a member of the study team on a session-by-session basis.

Determination of the blood flow restriction pressure

The participants were instructed to lay flat and relax. Over the tibial artery, a vascular Doppler probe (DV-600, Marted) was implanted to record an auscultatory pulse. An air cuff was placed around the patient’s thigh (inguinal fold area) and inflated until the auscultatory pulse was no longer audible, therefore establishing the cuff pressure (mm Hg) required for a full restriction of blood flow (i.e., pulse elimination pressure). The training programme calls for a cuff pressure of 70% of what is needed to completely limit blood flow while the individual is at rest. Complete blood flow restriction required an average cuff pressure of 139.2 10.8 mm Hg, whereas the average cuff pressure utilised all through the training procedure was 97.4 7.6 mm Hg. Sample Research Methodology.

Strength and functional tests

Two mild warm-up sets were completed two minutes apart before the 1-repetition maximum test. Patients then had up to five tries at lifting the 1-RM load, with a three-minute rest period in between each effort. In order to determine their respective 1-repetition maximums, the leg press and knee extension exercises were performed. The TUG and TST were used to assess physical capacity. The 30-second Timed Stand Test (TST) measures the number of times a person can stand up from a standard armless chair (45 cm of height), while the Timed Up and Go Test (TUG) measures the amount of time it takes for a person to stand up from a standard arm chair (45 cm of height), walk three metres to a line on the floor, turn around, return, and sit down again. No auxiliary aids were used throughout the testing sessions. All functional and strength tests were performed after at least 48 hours of familiarisation with the patient, which was done three times. Test-retest coefficients of variation (CV) were 5.86% for 1-repetition maximum (RM) leg press, 3.78% for 1-repetition maximum (RM) knee extension, 8.28% for TST, and 3.97% for TUG.

Quadriceps CSA

Quadriceps CSA was measured using computed tomography (Brilliance CT, 64-slice, Philips Medical System Technologies LTD). The patients were positioned supine with their knees bent and their legs straight. The subject’s leg mobility was restricted with a bandage during the evaluation. The segment length was calculated by obtaining an initial reference picture and measuring the horizontal distance from the greater trochanter of the femur to the inferior border of the lateral epicondyle of the femur. Halfway along the length of the quadriceps section, 0.8 cm slices were taken to determine CSA. The scanning parameters were as follows: 120 kV, 300 mA, 0.75 s rotation time, and 500 mm field of view. A trained researcher who was unaware of the patients’ treatments traced the quadriceps photos three times to get an accurate average. The coefficient of variation (CV) for the quadriceps CSA measurement was 0.73 percent. Sample Research Methodology.

Self-reported quality of life assessment

The WOMAC was used to assess levels of pain, stiffness, and ability to move. When measuring the wellness of elderly people with knee OA, this tool has been verified and is suggested by the Osteoarthritis Research Society. The function is rated on a scale from 0 (none) to 4 (extreme), with higher overall scores indicating more severe impairment. The SF-36, a 36-item short-form health survey with several uses, was also used to evaluate participants’ quality of life. Higher total scores indicate better health conditions, and it produces a profile of functional health and well-being scores and also psychometrically-based physical and mental health summary indicators.

Ethical consideration

The investigation will be carried out with careful consideration given to all of the aspects identified in advance as necessary for the research. The plan will be implemented, and for the same reasons, information gathered from secondary sources will be collated. The most important ethical problems will be kept in mind during the whole of the investigation, and it will be planned that suitable citations and references will be retained for the sake of data gathering. It will be essential to enter a password to access the personal computers and flash drives that will house the necessary auxiliary resources. Additionally, pre-existing literary works won’t be read for entertainment; instead, they will be utilized only for academic study. This decision was made to preserve the integrity of the results. Before beginning, each participant will be told that their involvement in the study is entirely voluntary. Then the necessary procedures will be followed to get the participants’ consent on the matter. During the study, the participants will in no way be coerced or intimidated into giving their consent to any intervention or action involving the collection of data that will be carried out. They won’t have any need to be worried about retaliation coming from their side of things at all. Sample Research Methodology.

Last but not least, the conclusions of the case study, as well as the information obtained from the company that will be the primary focus of the research, will be kept in the strictest confidence. If it is considered that the information and findings need to be shared with the proper authorities, then the appropriate charges will be notified. Before the online jot form can be completed, the participants’ authorization will be required. The customers will first be given complete and correct information about the news that has been supplied to them and the terms and conditions of the agreement before any information is shared with them. It ensures that the information collected from the participants’ responses is accurate. Sample Research Methodology.

References

van Hecke, O., Torrance, N., & Smith, B. H. (2013). Chronic pain epidemiology and its clinical relevance. British Journal of Anaesthesia, 111(1), 13–18. https://doi.org/10.1093/bja/aet123

van Wilgen, C. P., & Keizer, D. (2012). The sensitization model explains how chronic pain exists without tissue damage. Pain Management Nursing, 13(1), 60–65. https://doi.org/10.1016/j.pmn.2010.03.001

Verhoeven, F., Tordi, N., Prati, C., Demougeot, C., Mougin, F., & Wendling, D. (2016). Physical activity in patients with rheumatoid arthritis. Joint Bone Spine, 83(3). https://doi.org/10.1016/j.jbspin.2015.10.002

Vopat, B. G., Vopat, L. M., Bechtold, M. M., & Hodge, K. A. (2020). Blood flow restriction therapy: where we are and where we are coing. Journal of the American Academy of Orthopaedic Surgeons, 28(12). https://doi.org/10.5435/JAAOS-D-19-00347

Walsh, D. A., & McWilliams, D. F. (2012). Pain in Rheumatoid Arthritis. Current Pain and Headache Reports, 16(6). https://doi.org/10.1007/s11916-012-0303-x

Wolfe, F., Häuser, W., Hassett, A. L., Katz, R. S., & Walitt, B. T. (2011). The development of fibromyalgia – I: Examination of rates and predictors in patients with rheumatoid arthritis (RA). Pain, 152(2), 291–299. https://doi.org/10.1016/j.pain.2010.09.027

Wortman, R. J., Brown, S. M., Savage-Elliott, I., Finley, Z. J., & Mulcahey, M. K. (2021). blood flow restriction training for athletes: A systematic review. The American Journal of Sports Medicine, 49(7). https://doi.org/10.1177/0363546520964454

Zautra, A. J., Parrish, B. P., van Puymbroeck, C. M., Tennen, H., Davis, M. C., Reich, J. W., & Irwin, M. (2007). Depression history, stress, and pain in rheumatoid arthritis patients. Journal of Behavioral Medicine, 30(3). https://doi.org/10.1007/s10865-007-9097-4

Hernigou, P., & Scarlat, M. M. (2022). Growth in musculoskeletal pathology worldwide: the role of Société Internationale de Chirurgie Orthopédique et de Traumatologie and publications. International Orthopaedics, 1-8.

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