Effects of Inspiratory Muscle Training (IMT) on Balance Ability and Quality of Life of Diabetes Mellitus Patients

NCT04947163 | Completed DMC

• 1 other identifier: REC/13564 Suman Sheraz
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The disease burden of Diabetes Mellitus (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

Diabetes Mellitus

Keywords

Balance; Diabetes Mellitus; Inspiratory Muscle Training; Quality of life

Outcome Measures

Primary Outcomes (6)

• Fall risk score

  Fall risk score will be calculated by Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. Higher scores of fall risk score indicate greater balance deterioration and thus increase risk of fall. It would be assessed at baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

• Overall stability index

  Overall stability index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

• Anterior / Posterior index

  Anterior / Posterior index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

• Medial / lateral index

  Medial / lateral index will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

• Modified Clinical Test of Sensory Interaction in Balance (M - CTSIB) (composite score)

  Modified Clinical Test of Sensory Interaction in Balance (M - CTSIB) will be calculated through Biodex Postural Stability system which is a highly reliable and objective measure for assessment of balance. It provides a 20o surface tilt in all 360 degree directions while providing an adjustable spring resistance to mobile surface from a static base of support at level 12 to a fully mobile base of support of level 1 same as wobble board like movements. It would be assessed at baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

• Audit of Diabetes Dependent Quality of Life:

  Audit of Diabetes Dependent Quality of Life (ADDQOL) is a reliable questionnaire used to measure individual's perception of the impact of diabetes on their quality of life. The scales range from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Lower scores reflect poorer quality of life. It would be assessed ay baseline, after 12 weeks and after 6months of intervention.

  After 12 weeks of intervention

Secondary Outcomes (8)

• Peak expiratory flow rate (PEFR)

  After 12 weeks of intervention

• Forced vital capacity (FVC)

  After 12 weeks of intervention

• Forced expiratory volume in 1sec (FEV1)

  After 12 weeks of intervention

• FVC/FEV1

  After 12 weeks of intervention

• Biering-Sørensen tests

  After 12 weeks of intervention

Study Arms (2)

IMT group

EXPERIMENTAL

* 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.

Device: Inspiratory Muscle Training

Sham IMT

SHAM COMPARATOR

* 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.

Device: Sham IMT

Interventions

Inspiratory Muscle Training DEVICE

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.

IMT group

Sham IMT DEVICE

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.

Sham IMT

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mini Mental State Examination (MMSE) score \>24
• Type II diabetes: Post 5-8 years diagnosis
• Berg Balance score (30-40)
• Presence of polyneuropathy confirmed through Modified Toronto Clinical Scoring System.

You may not qualify if:

• Patients on oxygen therapy
• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital, Riphah Rehabilitation Center

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (11)

• 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.

  PMID: 27525281 BACKGROUND

• 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.

  PMID: 31074198 BACKGROUND

• 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.

  PMID: 27765575 BACKGROUND

• 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.

  PMID: 24453703 BACKGROUND

• 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.

  PMID: 32705393 BACKGROUND

• 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.

  PMID: 29424007 BACKGROUND

• 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.

  PMID: 26957739 BACKGROUND

• 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.

  PMID: 29984598 BACKGROUND

• 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.

  PMID: 18172412 BACKGROUND

• 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.

  PMID: 31978126 BACKGROUND

• 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.

  PMID: 39284701 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arshad Nawaz Malik, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 1, 2021
• Study Start: July 1, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication till 36months
• Access Criteria: on reasonable request

Locations

PA (1)