Progressive Muscle Relaxation Technique on Lower Limb Amputation

NCT04051164 | Completed DMC

• 1 other identifier: RiphahIU Khola Pervaiz
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

Amputation; Progressive Muscle Relaxation Technique; Pulmonary Function; Stress

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Progressive Muscle Relaxation Technique

EXPERIMENTAL

Progressive muscle relaxation technique

Other: Progressive Muscle Relaxation Technique

Conventional treatment

ACTIVE COMPARATOR

Conventional Treatment: (Strengthening exercises of residual limb, Gait training, Deep Breathing exercise)

Other: Conventional treatment

Interventions

Progressive Muscle Relaxation Technique OTHER

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.

Progressive Muscle Relaxation Technique

Conventional treatment OTHER

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.

Conventional treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Lower Limb amputation (up to level of trans femoral)immediate after surgery
• Single leg Amputated patients
• Both Genders.
• Amputation as a result of Diabetes Mellitus (DM) , trauma, burns and Electric Burn, Peripheral vascular disorders

You may not qualify if:

• Vitally unstable Patients.
• Patients with diagnosed respiratory disease.
• Any neurological Symptoms.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 16291066 BACKGROUND

• 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.

  PMID: 23992892 BACKGROUND

• 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.

  PMID: 22533668 BACKGROUND

• 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.

  PMID: 11719314 BACKGROUND

• 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.

  PMID: 10702166 BACKGROUND

• 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.

  PMID: 19675392 BACKGROUND

• 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.

  PMID: 6143184 BACKGROUND

• 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.

  PMID: 26573455 BACKGROUND

• 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.

  PMID: 15338385 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Iqbal Tariq, MSCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: February 20, 2019
• Primary Completion: June 15, 2019
• Study Completion: June 20, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)