NCT04051164|CompletedDMC
Progressive Muscle Relaxation Technique on Lower Limb Amputation
Effects of Progressive Muscle Relaxation Technique on Pulmonary Functions and Stress on Lower Limb Amputation
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Effects of Progressive Muscle Relaxation Technique on Pulmonary Functions and Stress on Lower Limb Amputation
Sponsor study identifier
interventional
40
1 country
1
Study Start
February 20, 2019
Actual (reported)Primary Completion
June 15, 2019
Actual (reported)Study Completion
June 20, 2019
Actual (reported)To determine the effects of progressive muscle relaxation technique on pulmonary functions in lower limb amputation patients. Randomized control Trail study design was chosen for this study, sampling technique Non probability convenient sampling then randomly allocated into groups by coin toss method. The subject in experimental group (n=20) were provided PMRT twice a day for one week and conventional treatment (n=20) was provided to control group. Modified perceived stress scale was used to find the effect of PMRT on stress, and pulmonary function was measured by digital spirometer..
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 20, 2019
Actual (reported)June 15, 2019
Actual (reported)June 20, 2019
Actual (reported)August 8, 2019
Actual (reported)August 9, 2019
Actual (reported)Forced vital Capacity (FVC)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
1 week
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
1 week
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second
1 week
Modified perceived stress scale
Perceived stress scale was developed in 1983, (36) and most commonly used to measure the degree to which situation in one's life are appraised as stressful. Modified perceived stress scale which consist of 10 items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4).
2 week
Progressive muscle relaxation technique
Conventional Treatment: (Strengthening exercises of residual limb, Gait training, Deep Breathing exercise)
PMRT begins by assuming a comfortable position of lying down, sitting or leaning back. Patient is asked to take a breathe in and intentionally contract muscle and hold muscle and after that release all tension and focus on sensation of relaxation. Each muscle group is tensed for 5-7 seconds and relaxed for 20-30 seconds. PMRT is given twice a day for one week.
Strengthening exercises of residual limb: After amputation strengthening exercises of residual limb is necessary to prevent shortening of muscles and tightening of joints, moreover it is necessary to make residual limb strong and flexible in order to use a prosthesis. This include Hip abduction, prone hip extension and Prone position. Gait training: This include standing exercises in the parallel bars with or without the prosthesis. Initial walking exercises in which the patient is taught to raise each knee alternately and to try to take weight on his limb as much as possible. Deep Breathing exercise: Deep breathing 10-15 repetitions twice a day.
Riphah International University
Islamabad, Federal, 44000, Pakistan
Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.
Margolis DJ, Jeffcoate W. Epidemiology of foot ulceration and amputation: can global variation be explained? Med Clin North Am. 2013 Sep;97(5):791-805. doi: 10.1016/j.mcna.2013.03.008. Epub 2013 Apr 25.
Feinglass J, Shively VP, Martin GJ, Huang ME, Soriano RH, Rodriguez HE, Pearce WH, Gordon EJ. How 'preventable' are lower extremity amputations? A qualitative study of patient perceptions of precipitating factors. Disabil Rehabil. 2012;34(25):2158-65. doi: 10.3109/09638288.2012.677936. Epub 2012 Apr 25.
Iqbal Tariq, MSCPPT
Riphah International University
40 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2019
First Posted
August 9, 2019
Study Start
February 20, 2019
Actual (reported)C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.
Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8. doi: 10.1093/ajcn/71.3.733.
Dehdari T, Heidarnia A, Ramezankhani A, Sadeghian S, Ghofranipour F. Effects of progressive muscular relaxation training on quality of life in anxious patients after coronary artery bypass graft surgery. Indian J Med Res. 2009 May;129(5):603-8.
Little BC, Hayworth J, Benson P, Hall F, Beard RW, Dewhurst J, Priest RG. Treatment of hypertension in pregnancy by relaxation and biofeedback. Lancet. 1984 Apr 21;1(8382):865-7. doi: 10.1016/s0140-6736(84)91337-0.
Akgun Sahin Z, Dayapoglu N. Effect of progressive relaxation exercises on fatigue and sleep quality in patients with chronic obstructive lung disease (COPD). Complement Ther Clin Pract. 2015 Nov;21(4):277-81. doi: 10.1016/j.ctcp.2015.10.002. Epub 2015 Oct 19.
Dimeo FC, Thomas F, Raabe-Menssen C, Propper F, Mathias M. Effect of aerobic exercise and relaxation training on fatigue and physical performance of cancer patients after surgery. A randomised controlled trial. Support Care Cancer. 2004 Nov;12(11):774-9. doi: 10.1007/s00520-004-0676-4.
Primary Completion
June 15, 2019
Actual (reported)Study Completion
June 20, 2019
Actual (reported)Last Updated
August 12, 2019
Record last verified: 2019-08
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