Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients
NCT ID: NCT04947163
Last Updated: 2024-03-05
Study Results
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Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2021-07-01
2022-12-06
Brief Summary
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Detailed Description
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Clinically, there are different complications (micro \& macro vascular) associated with DM and these are main sources of morbidity and mortality. Neuropathy, nephropathy, and retinopathy are the microvascular complications whereas macrovascular complications include cardiovascular diseases, stroke as well as other vascular diseases. Apart from these complications, there are few other complications including decreased resistance to infections, dental issues, birth complications in gestational diabetes, poor balance, sarcopenia and increased risk of fall and fractures. The reduced strength and endurance of diaphragm the vital muscle of respiration lead to compromised respiratory functions.
Peripheral neuropathy, retinopathy and vestibular impairments alter the biomechanical stability and strength of postural control in individuals with DM. The instability generates disparity among muscular and neural structures to execute locomotion abilities, so abnormal gait pattern, weakness in lower limb musculature, impair sensory function, diminished reflexes and high fall risk have been observed.
These musculoskeletal complications compromise the mobility level and impede the performance of functional tasks and Activities of Daily Life (ADLs) in patients with DM. The limited movements and participation restrictions in social activities create inaccessibility and dependence on caregiver has been increased. The overall activity level has been declined and decreases the quality of life of individuals and ultimately developing social and economic burden on community.
Management of DM always emphases to improve the current health status and prevent further complications due to uncontrolled DM. Multiple management approaches have been reported in the literature to maintain adequate glycemic control and manage diabetes related complications and co morbidities. Treatment strategies also focus to maximize the quality of life and minimize the risk of treatment related complications including hypoglycemia. Balance and postural impairments are common in DM due to neuropathic changes and there are different training strategies have been documented in literature to improve postural stability and reduce fall risk. The training approaches include Tai Chi, Wii Fit based training, circuit training, strengthening exercises of lower limbs, gait training and task oriented dynamic training to enhance the overall balance abilities.
The central trunk stability and core strength are integral part of postural stability and balance but there is limited evidence to address these for balance training in DM. There is lacking evidence in literature on specific training targeting the central trunk and core strength to improve the balance ability, reduces fall risk and improve quality of life in DM patients.
Inspiratory Muscle Training (IMT) is a device-based training and widely used therapeutic technique for improving inspiratory muscle strength and endurance, thoracic mobility, exercise capacity, reducing dyspnea and increasing quality of life. Recently, IMT has been used to improve balance and physical performance among elderly.
How IMT is a useful intervention to improve cardiopulmonary function, postural control and quality of life? The underlying mechanism of IMT principal and clinical implications has three-fold mechanisms:
First: Diaphragm thickness and strength enhances balance in two ways. Firstly, there is activation of diaphragm during upper limb movements indicating that the co-activation of diaphragm assists in the mechanical stabilization of the spine. Secondly, it plays a major role in the generation of intra-abdominal pressure which helps in the stabilization of lumbar spine during movements like shoulder abduction and adduction i.e., balance perturbations. These changes will improve the lower limb mobility, quadriceps strength, functional performance, postural control response and exercise tolerance among individuals. It creates an overall impact on enhanced balance strategies, physical performance and postural stability in elderly and other pathological conditions including chronic obstructive pulmonary disease (COPD), cystic fibrosis and stroke.
Second: Increases in diaphragmatic mobility and hypertrophy as well as improved neural control and thickness of respiratory muscles including transversus abdominus and internal obliques leads to increase in exercise capacity, pulmonary function and decreased perceived breathlessness and exertion in the patients. It will increase the strength of respiratory muscles ultimately proving it to be an effective treatment strategy in COPD, chronic heart failure, multiple sclerosis and various respiratory diseases.
Third: IMT exerts certain ergogenic effects through increasing diaphragmatic mobility and strength thereby improving the recovery time in sprinters, limiting cardiac sympathetic hyperactivity in cyclists and enhance rowing performance.
Therefore, it can be hypothesized that IMT is not only effective for improving cardiopulmonary function but is also strongly linked with postural stability. The disease burden of DM is growing rapidly, and multiple complications have been reported including cardiopulmonary and high fall risk which declines the overall quality of life. IMT can be useful technique to improve the physical and functional performance, reduce the severity of complications and enable the individuals to become active members of community. The current study is intended to evaluate the dual effects of IMT on postural stability and pulmonary function of diabetic patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IMT group
* Standard exercise protocol according to ACSM's guidelines Standard exercise protocol according to ACSM's guidelines
* Balance training - Otago Exercise Program (OEP)
* warm-up (10-15 min)
* strengthening exercises (\~20 min)
* balance activities (\~20 min)
* cool-down (5-10 min) Balance training - OEP
* warm-up (10-15 min)
* strengthening exercises (\~20 min)
* balance activities (\~20 min)
* cool-down (5-10 min)
* IMT through POWERBREATHE
* 30 quick breaths twice daily at an adjustable resistance (equivalent to \~50% of \[baseline\] MIP).
* Will be increased up to 35 breaths as per patient's tolerance Sham IMT
* 60 slow breaths once daily at a load setting of 0 (corresponding to \~15% \[baseline\] MIP)
* training load adjustment will be prevented using sticky tape applied to the device's load adjuster.
Inspiratory Muscle Training
Participants will perform home-based IMT twice daily \[once in the morning (between 7:00 and 12:00 am) and once in the evening (between 16:00 and 21:00 pm)\], for 8 consecutive weeks, using a mechanical pressure threshold loading device. In addition, participants in this group will try to increase the inspiratory resistance when the participants feel that 30 breaths are achievable with ease or if the participants could reach 35 consecutive breaths.
Sham IMT
* Standard exercise protocol according to ACSM's guidelines Standard exercise protocol according to ACSM's guidelines
* Balance training - OEP
* warm-up (10-15 min)
* strengthening exercises (\~20 min)
* balance activities (\~20 min)
* cool-down (5-10 min) Balance training - OEP
* warm-up (10-15 min)
* strengthening exercises (\~20 min)
* balance activities (\~20 min)
* cool-down (5-10 min)
* IMT through POWERBREATHE
* 30 quick breaths twice daily at an adjustable resistance (equivalent to \~50% of \[baseline\] MIP).
* Will be increased up to 35 breaths as per patient's tolerance Sham IMT
* 60 slow breaths once daily at a load setting of 0 (corresponding to \~15% \[baseline\] MIP)
* training load adjustment will be prevented using sticky tape applied to the device's load adjuster.
Sham IMT
Participants will perform 60 slow breaths once daily at a load setting of 0 (corresponding to \~15% \[baseline\] MIP), using the same device as the IMT group. For the sham group, the ability to adjust the training load will be prevented using sticky tape applied to the device's load adjuster.
Interventions
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Inspiratory Muscle Training
Participants will perform home-based IMT twice daily \[once in the morning (between 7:00 and 12:00 am) and once in the evening (between 16:00 and 21:00 pm)\], for 8 consecutive weeks, using a mechanical pressure threshold loading device. In addition, participants in this group will try to increase the inspiratory resistance when the participants feel that 30 breaths are achievable with ease or if the participants could reach 35 consecutive breaths.
Sham IMT
Participants will perform 60 slow breaths once daily at a load setting of 0 (corresponding to \~15% \[baseline\] MIP), using the same device as the IMT group. For the sham group, the ability to adjust the training load will be prevented using sticky tape applied to the device's load adjuster.
Eligibility Criteria
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Inclusion Criteria
* Type II diabetes: Post 5-8 years diagnosis
* Berg Balance score (30-40)
* Presence of polyneuropathy confirmed through Modified Toronto Clinical Scoring System.
Exclusion Criteria
* Uncontrolled diabetes (Confirmed through HbA1C) or disease exacerbation in last 3 months.
* Patients practicing regular physical activity, any balance training in the last 6 months and previous or current experience with IMT
* Patients with musculoskeletal comorbidities that may impair exercise performance
* Peripheral oxygen saturation (SpO2) \< 90% during the Six-Minute Walk Test (6MWT)
* Patients with long COVID syndrome
* Hypertensive subjects without control medication as well as those presenting with a hypertensive peak (\> 140/90 mmHg) for more than 3 consecutive days
* Patients with cardiorespiratory diseases or patients taking drugs that effect balance e.g., beta blockers, anti-anxiety and anti-depressant drugs.
50 Years
70 Years
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Arshad Nawaz Malik, PhD
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
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Pakistan Railway Hospital, Riphah Rehabilitation Center
Rawalpindi, Punjab Province, Pakistan
Countries
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References
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Mustapa A, Justine M, Mohd Mustafah N, Jamil N, Manaf H. Postural Control and Gait Performance in the Diabetic Peripheral Neuropathy: A Systematic Review. Biomed Res Int. 2016;2016:9305025. doi: 10.1155/2016/9305025. Epub 2016 Jul 20.
Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
Chapman A, Meyer C, Renehan E, Hill KD, Browning CJ. Exercise interventions for the improvement of falls-related outcomes among older adults with diabetes mellitus: A systematic review and meta-analyses. J Diabetes Complications. 2017 Mar;31(3):631-645. doi: 10.1016/j.jdiacomp.2016.09.015. Epub 2016 Sep 30.
Pfalzer L, Fry D. Effects of a 10-week inspiratory muscle training program on lower-extremity mobility in people with multiple sclerosis: a randomized controlled trial. Int J MS Care. 2011 Spring;13(1):32-42. doi: 10.7224/1537-2073-13.1.32.
Rodrigues GD, Gurgel JL, Galdino IDS, da Nobrega ACL, Soares PPDS. Inspiratory muscle training improves cerebrovascular and postural control responses during orthostatic stress in older women. Eur J Appl Physiol. 2020 Oct;120(10):2171-2181. doi: 10.1007/s00421-020-04441-2. Epub 2020 Jul 23.
Shei RJ, Chapman RF, Gruber AH, Mickleborough TD. Inspiratory muscle training improves exercise capacity with thoracic load carriage. Physiol Rep. 2018 Feb;6(3):e13558. doi: 10.14814/phy2.13558.
Oh D, Kim G, Lee W, Shin MM. Effects of inspiratory muscle training on balance ability and abdominal muscle thickness in chronic stroke patients. J Phys Ther Sci. 2016 Jan;28(1):107-11. doi: 10.1589/jpts.28.107. Epub 2016 Jan 30.
Gomes Neto M, Ferrari F, Helal L, Lopes AA, Carvalho VO, Stein R. The impact of high-intensity inspiratory muscle training on exercise capacity and inspiratory muscle strength in heart failure with reduced ejection fraction: a systematic review and meta-analysis. Clin Rehabil. 2018 Nov;32(11):1482-1492. doi: 10.1177/0269215518784345. Epub 2018 Jul 9.
Fry DK, Pfalzer LA, Chokshi AR, Wagner MT, Jackson ES. Randomized control trial of effects of a 10-week inspiratory muscle training program on measures of pulmonary function in persons with multiple sclerosis. J Neurol Phys Ther. 2007 Dec;31(4):162-72. doi: 10.1097/NPT.0b013e31815ce136.
Ferraro FV, Gavin JP, Wainwright TW, McConnell AK. Comparison of balance changes after inspiratory muscle or Otago exercise training. PLoS One. 2020 Jan 24;15(1):e0227379. doi: 10.1371/journal.pone.0227379. eCollection 2020.
Sheraz S, Malik AN, Ferraro FV, Siddiqi FA. Does multifactorial inspiratory muscle training improve postural stability and quality of life of patients with diabetes in Pakistan? A randomised controlled trial. BMJ Open. 2024 Sep 16;14(9):e080718. doi: 10.1136/bmjopen-2023-080718.
Other Identifiers
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REC/13564 Suman Sheraz
Identifier Type: -
Identifier Source: org_study_id
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