Lower Limb Amputation Above Knee (Injury)NCT04051164
Progressive Muscle Relaxation Technique on Lower Limb Amputation
A study testing Progressive Muscle Relaxation Technique and Conventional treatment in people with Lower Limb Amputation Above Knee (Injury), run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury)
- What is being tested?
- Progressive Muscle Relaxation Technique and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2019to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Vitally unstable Patients.
- Patients with diagnosed respiratory disease.
- Any neurological Symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Muscle Relaxation Technique on Pulmonary Functions and Stress on Lower Limb Amputation
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..
Read the detailed description
Normal functioning of cardiovascular system are controlled by autonomic nervous system. Stress causes autonomic imbalance which increases sympathetic activity. Loss of limb is potentially stressful change in one's life resulting in vast physical, occupational and psycho-social changes. Amputation is the removal of any part of body, when all other reconstructive strategies have failed. Lower limb amputation caused by diabetes annually costs between $30,000 to $60,000 and throughout life costs half a million dollar. It was estimated in 2012 that lower extremity wound and diabetes in U.S medicare program cost about $41 million dollar which is almost estimated as ~1.6 of all medicare health spending (1-4), however in U.K national health care spent almost an amount of £639 and 662 million on foot ulcers, which was approximately £1 in every £150 spent by the National Health Service.
Other studies done on cost of diabetic foot ulcer (DFU) in Belgium showed Us $10,572 and in Sweden total cost for healing was US$24,965/patient with no amputation while they were US $47,518 and US$42,858 with amputation with minor and major surgeries respectively. Amputation due to congenital deformity is les common and present in only 1% of total amputation done. Acquired amputations include Peripheral vascular disease, trauma, malignancy, metabolic and infection. 2 million people or even more in US are living with loss of limb, and accounts for 10 times more amputation in people with diabetes in comparison with those who don't have diabetes according to World health organization.
Musculoskeletal imbalances or pathologies often develop into secondary physical conditions or complications that may affect the mobility and quality of life of people with lower limb amputation. Using one or more prostheses causes people with amputation to alter the biomechanics of their movement. For example, people with lower-limb amputation often favor and stress their intact lower limb more during everyday activities.
This can lead to degenerative changes such as osteoarthritis of the knee and/or hip joints of the intact limb. Since people with amputation spend less time on their residual limb, osteopenia and subsequent osteoporosis often occur secondary to insufficient loading through the long bones of the lower limb. A proper prosthetic fit increases the probability of equal force distribution across the intact and prosthetic limbs during ambulation, thus decreasing the risk of osteoarthritis. People with limb loss commonly complain of back pain, which is linked to poor prosthetic fit and alignment, postural changes, leg-length discrepancy, amputation level, and general deconditioning. We review the literature on secondary complications among people with lower limb loss who are long-term prosthesis wearers.(outcomes of amputation) Secondary complications are of great importance in patients who have undergone traumatic amputation, main 2 systems that are effected are musculoskeletal and cardiovascular system. Mostly hospitalized patients acquire lying position which include spine, prone or right and left side lying position, change of position after every 2 hours is recommended to avoid contractures or bed sores, positioning is also required for good oxygen saturation and drainage of secretion, recumbency causes accumulation of secretions. Number of people having paraplegia and other disorders related to Central nervous system (CNS) are increasing due to metabolic disorder and increased blood pressure and most patients with CNS disorder are bed bound.
Estimation of pulmonary functions in various body postures they concluded that body position has a significant effect on spirometric measures like forced vital capacity (FVC), Forced expired volume in 1 second (FEV1) and FEV1%, generally. The standing position has highest lung volume and chair sitting to the second highest lung volumes. In recumbent position, factors causing impaired lung function include external compression of chest wall, compression of abdominal contents on diaphragm, compression of airway and blood vessels by heart.
Progressive muscle Relaxation Technique (PMRT) is one of the non pharmacological interventions to overcome these problems. It decreases stress through its effect on mental and physical conditions, mood, depression, and anxiety. Relaxation methods are very powerful tools for dealing with stress, depression and anxiety by giving the body/mind the chance to make its own healing.
Effect of of progressive muscle relaxation technique on Chronic Obstructive pulmonary Disease (COPD) patients and concluded that PMRT demonstrates an effective intervention approach for improving pulmonary function by reducing COPD-related fatigue and sleep quality.
Meta analysis on for collecting the evidence of effectiveness of relaxation techniques on pulmonary function of patients with COPD. They concluded that relaxation techniques improve oxygen saturation and heart rate therefore improving pulmonary function.
Randomized controlled trial on seventy two individuals with lung or gastrointestinal tumours to determine the effectiveness of relaxation techniques. It was concluded that progressive relaxation training is effective in improving fatigue and physical performance of cancer patients.
Prolong immobilization due to amputation badly effect pulmonary function, previously no study was done to know the effect of PMRT on pulmonary function. Effect of relaxation was seen in asthmatic children, asthma is a condition in which airway is narrowed, swell and produce extra mucus. For more than a period of 10 years it has been common place for physician and other dealing with asthmatic patients to ask them to relax at the onset of asthmatic attacks, there is no empirical data available but patient report and clinical experience suggested that relaxation can improve wheezing.
- Being tested
- Progressive Muscle Relaxation Technique, Conventional treatment
- Keywords
- Amputation, Progressive Muscle Relaxation Technique, Pulmonary Function, Stress
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation TechniqueOther
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.
Conventional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Technique | Experimental | Progressive muscle relaxation technique Receives: Other: Progressive Muscle Relaxation Technique |
| Conventional treatment | Active comparator | Conventional Treatment: (Strengthening exercises of residual limb, Gait training, Deep Breathing exercise) Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital Capacity (FVC)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Measured: 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
Measured: 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
Measured: 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).
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start20 Feb 2019
- Primary completion15 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051164
- Sponsor's protocol ID
- RiphahIU Khola Pervaiz
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16291066Margolis 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.
PubMed 23992892Feinglass 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.
PubMed 22533668Debigare 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.
PubMed 11719314Engelen 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.
PubMed 10702166Dehdari 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.
PubMed 19675392Little 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.
PubMed 6143184Akgun 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.
PubMed 26573455Dimeo 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.
PubMed 15338385
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Muscle Relaxation Technique on Pulmonary Functions and Stress on Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT04051164
- Acronym / sponsor ID
- RiphahIU Khola Pervaiz
- Keywords
- Amputation, Progressive Muscle Relaxation Technique, Pulmonary Function, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
Normal functioning of cardiovascular system are controlled by autonomic nervous system. Stress causes autonomic imbalance which increases sympathetic activity. Loss of limb is potentially stressful change in one's life resulting in vast physical, occupational and psycho-social changes. Amputation is the removal of any part of body, when all other reconstructive strategies have failed. Lower limb amputation caused by diabetes annually costs between $30,000 to $60,000 and throughout life costs half a million dollar. It was estimated in 2012 that lower extremity wound and diabetes in U.S medicare program cost about $41 million dollar which is almost estimated as ~1.6 of all medicare health spending (1-4), however in U.K national health care spent almost an amount of £639 and 662 million on foot ulcers, which was approximately £1 in every £150 spent by the National Health Service.
Other studies done on cost of diabetic foot ulcer (DFU) in Belgium showed Us $10,572 and in Sweden total cost for healing was US$24,965/patient with no amputation while they were US $47,518 and US$42,858 with amputation with minor and major surgeries respectively. Amputation due to congenital deformity is les common and present in only 1% of total amputation done. Acquired amputations include Peripheral vascular disease, trauma, malignancy, metabolic and infection. 2 million people or even more in US are living with loss of limb, and accounts for 10 times more amputation in people with diabetes in comparison with those who don't have diabetes according to World health organization.
Musculoskeletal imbalances or pathologies often develop into secondary physical conditions or complications that may affect the mobility and quality of life of people with lower limb amputation. Using one or more prostheses causes people with amputation to alter the biomechanics of their movement. For example, people with lower-limb amputation often favor and stress their intact lower limb more during everyday activities.
This can lead to degenerative changes such as osteoarthritis of the knee and/or hip joints of the intact limb. Since people with amputation spend less time on their residual limb, osteopenia and subsequent osteoporosis often occur secondary to insufficient loading through the long bones of the lower limb. A proper prosthetic fit increases the probability of equal force distribution across the intact and prosthetic limbs during ambulation, thus decreasing the risk of osteoarthritis. People with limb loss commonly complain of back pain, which is linked to poor prosthetic fit and alignment, postural changes, leg-length discrepancy, amputation level, and general deconditioning. We review the literature on secondary complications among people with lower limb loss who are long-term prosthesis wearers.(outcomes of amputation) Secondary complications are of great importance in patients who have undergone traumatic amputation, main 2 systems that are effected are musculoskeletal and cardiovascular system. Mostly hospitalized patients acquire lying position which include spine, prone or right and left side lying position, change of position after every 2 hours is recommended to avoid contractures or bed sores, positioning is also required for good oxygen saturation and drainage of secretion, recumbency causes accumulation of secretions. Number of people having paraplegia and other disorders related to Central nervous system (CNS) are increasing due to metabolic disorder and increased blood pressure and most patients with CNS disorder are bed bound.
Estimation of pulmonary functions in various body postures they concluded that body position has a significant effect on spirometric measures like forced vital capacity (FVC), Forced expired volume in 1 second (FEV1) and FEV1%, generally. The standing position has highest lung volume and chair sitting to the second highest lung volumes. In recumbent position, factors causing impaired lung function include external compression of chest wall, compression of abdominal contents on diaphragm, compression of airway and blood vessels by heart.
Progressive muscle Relaxation Technique (PMRT) is one of the non pharmacological interventions to overcome these problems. It decreases stress through its effect on mental and physical conditions, mood, depression, and anxiety. Relaxation methods are very powerful tools for dealing with stress, depression and anxiety by giving the body/mind the chance to make its own healing.
Effect of of progressive muscle relaxation technique on Chronic Obstructive pulmonary Disease (COPD) patients and concluded that PMRT demonstrates an effective intervention approach for improving pulmonary function by reducing COPD-related fatigue and sleep quality.
Meta analysis on for collecting the evidence of effectiveness of relaxation techniques on pulmonary function of patients with COPD. They concluded that relaxation techniques improve oxygen saturation and heart rate therefore improving pulmonary function.
Randomized controlled trial on seventy two individuals with lung or gastrointestinal tumours to determine the effectiveness of relaxation techniques. It was concluded that progressive relaxation training is effective in improving fatigue and physical performance of cancer patients.
Prolong immobilization due to amputation badly effect pulmonary function, previously no study was done to know the effect of PMRT on pulmonary function. Effect of relaxation was seen in asthmatic children, asthma is a condition in which airway is narrowed, swell and produce extra mucus. For more than a period of 10 years it has been common place for physician and other dealing with asthmatic patients to ask them to relax at the onset of asthmatic attacks, there is no empirical data available but patient report and clinical experience suggested that relaxation can improve wheezing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Technique | Experimental | Other: Progressive Muscle Relaxation TechniqueProgressive muscle relaxation technique |
| Conventional treatment | Active comparator | Other: Conventional treatmentConventional Treatment: (Strengthening exercises of residual limb, Gait training, Deep Breathing exercise) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Vitally unstable Patients.
- Patients with diagnosed respiratory disease.
- Any neurological Symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle Relaxation TechniquePMRT 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. | Other | Progressive Muscle Relaxation Technique |
| Conventional treatmentStrengthening 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. | Other | Conventional treatment |
Primary outcome
Forced vital Capacity (FVC)
Time frame: 1 week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 1 week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Peak Expiratory Flow (PEF)
Time frame: 1 week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second
Modified perceived stress scale
Time frame: 2 week
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 16291066Boulton 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.
- Background: PubMed 23992892Margolis 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.
- Background: PubMed 22533668Feinglass 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.
- Background: PubMed 11719314Debigare 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.
- Background: PubMed 10702166Engelen 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.
- Background: PubMed 19675392Dehdari 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.
- Background: PubMed 6143184Little 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.
- Background: PubMed 26573455Akgun 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.
- Background: PubMed 15338385Dimeo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal Tariq, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation Technique and Conventional treatment in people with Lower Limb Amputation Above Knee (Injury), run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital Capacity (FVC) (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051164, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.