CClinicalTrials.gg
CompletedNCT04636658Updated Nov 19, 2020

Effects of Resistive Diaphragmatic Training on Chronic Stroke

An interventional study of Incentive spirometer training and diaphragmatic resistance exercises in Stroke (CVA) or TIA, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2020, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 50 Years
Sex
All
01

Study summary

To determine the effects of resistive diaphragmatic training on pulmonary function of chronic stroke patients. And also assessing their compromised respiratory functions

Read the detailed description

This study is to examine the effects of Diaphragmatic breathing exercises with resistance and Digital spirometer training for improving pulmonary functions in chronic stroke patients. Diaphragmatic Resistance training is based on the same principal as for the any other Skeletal Muscle training. The selection of 20 subjects divided equally and placed into an experimental group and a control group and the interventions would applied three times per week for 4 weeks. In each session, both groups receive Digital spirometer training for 15 minutes. In addition, experimental group receive diaphragm breathing exercises with resistance for 30 minutes. Resistance is Applied through Different thera bands and then performing the Breathing Exercises. First of all resistance applied through yellow band(1-6 pounds of resistance) and then red, Green and black which give (4-18 Pounds of resistance) The patient is asked to breath in deeply and slowly while not to move upper chest .Weight increased weekly as per patient's tolerance. Further Digital spirometer training Perform to determine the Pulmonary Functions FVC,FEV1,FVC/FEV1,PEF,VC. in both Control and Experimental Groups

02

Conditions studied

  • Stroke (CVA) or TIA

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Keywords

  • stroke
  • resistive diaphragmatic training
  • pulmonary function
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age limit 40-50yrs both genders.
  • Stroke patients with compromised pulmonary functions.
  • Chronic stroke patients with impaired Breathing

Exclusion criteria

Exclusion Criteria:

  • Patients having any systemic illness
  • Patients who have a damage accompanying orthopedic disease such as thoracic deformation or rib fracture.
  • Patients with stroke (less than 6 months duration)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Incentive spirometer training

    Incentive spirometer training

    Other: Incentive spirometer training

  • Experimental
    diaphragmatic resistance exercises

    Incentive spirometer training with diaphragm breathing with resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient

    Other: diaphragmatic resistance exercises

Interventions

  • OtherIncentive spirometer training

    Incentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks

  • Otherdiaphragmatic resistance exercises

    Incentive spirometer with diaphragmatic resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient. Digital spirometer training for 15 minutes. diaphragm breathing exercises with resistance for 30 minutes. 5 sessions a week, for 4 weeks

06

What researchers measure

Primary outcomes

  1. FEV1

    FEV1 is the amount of air you can force from your lungs in one second. It's measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine.

    Time frame: 4th week

  2. FVC

    Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. Forced expiratory volume and forced vital capacity are lung function tests that are measured during spirometry. Forced expiratory volume is the most important measurement of lung function.

    Time frame: 4th week

  3. Oxygen level in blood

    Pulse oximetry is a test used to measure the oxygen level (oxygen saturation) of the blood

    Time frame: 4th week

  4. Heart Rate

    Pulse oximetry is a test used to measure the heart rate

    Time frame: 4th week

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Study locations

1 site
  • District Hospital Sargodha
    Sargodha, Punjab 40100, Pakistan
08

References and documents

Publications

  • Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23. PubMed 29791947 ↗
  • Di Carlo A. Human and economic burden of stroke. Age Ageing. 2009 Jan;38(1):4-5. doi: 10.1093/ageing/afn282. No abstract available. PubMed 19141505 ↗
  • Hochstenbach J, Donders R, Mulder T, Van Limbeek J, Schoonderwaldt H. Long-term outcome after stroke: a disability-orientated approach. Int J Rehabil Res. 1996 Sep;19(3):189-200. doi: 10.1097/00004356-199609000-00001. No abstract available. PubMed 8910122 ↗
  • Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. doi: 10.2471/BLT.16.181636. No abstract available. PubMed 27708464 ↗
  • Feigin VL, Krishnamurthi RV, Parmar P, Norrving B, Mensah GA, Bennett DA, Barker-Collo S, Moran AE, Sacco RL, Truelsen T, Davis S, Pandian JD, Naghavi M, Forouzanfar MH, Nguyen G, Johnson CO, Vos T, Meretoja A, Murray CJ, Roth GA; GBD 2013 Writing Group; GBD 2013 Stroke Panel Experts Group. Update on the Global Burden of Ischemic and Hemorrhagic Stroke in 1990-2013: The GBD 2013 Study. Neuroepidemiology. 2015;45(3):161-76. doi: 10.1159/000441085. Epub 2015 Oct 28. PubMed 26505981 ↗
  • Menezes KK, Nascimento LR, Ada L, Polese JC, Avelino PR, Teixeira-Salmela LF. Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. J Physiother. 2016 Jul;62(3):138-44. doi: 10.1016/j.jphys.2016.05.014. Epub 2016 Jun 16. Erratum In: J Physiother. 2018 Apr;64(2):73. doi: 10.1016/j.jphys.2018.02.005. PubMed 27320833 ↗
  • Cabral EEA, Resqueti VR, Lima INDF, Gualdi LP, Aliverti A, Fregonezi GAF. Effects of positive expiratory pressure on chest wall volumes in subjects with stroke compared to healthy controls: a case-control study. Braz J Phys Ther. 2017 Nov-Dec;21(6):416-424. doi: 10.1016/j.bjpt.2017.06.006. Epub 2017 Jul 8. PubMed 28736210 ↗
  • Menezes KK, Nascimento LR, Avelino PR, Alvarenga MTM, Teixeira-Salmela LF. Efficacy of Interventions to Improve Respiratory Function After Stroke. Respir Care. 2018 Jul;63(7):920-933. doi: 10.4187/respcare.06000. Epub 2018 May 29. PubMed 29844210 ↗
  • Lista Paz A, Gonzalez Doniz L, Ortigueira Garcia S, Saleta Canosa JL, Moreno Couto C. Respiratory Muscle Strength in Chronic Stroke Survivors and Its Relation With the 6-Minute Walk Test. Arch Phys Med Rehabil. 2016 Feb;97(2):266-72. doi: 10.1016/j.apmr.2015.10.089. Epub 2015 Oct 28. PubMed 26519610 ↗
  • Kashihara H, Haruna Y, Suzuki Y, Kawakubo K, Takenaka K, Bonde-Petersen F, Gunji A. Effects of mild supine exercise during 20 days bed rest on maximal oxygen uptake rate in young humans. Acta Physiol Scand Suppl. 1994;616:19-26. PubMed 8042521 ↗
  • Lee DK, Jeong HJ, Lee JS. Effect of respiratory exercise on pulmonary function, balance, and gait in patients with chronic stroke. J Phys Ther Sci. 2018 Aug;30(8):984-987. doi: 10.1589/jpts.30.984. Epub 2018 Jul 24. PubMed 30154586 ↗
  • Oh DS, Park SE. The effect of lumbar stabilization exercise on the pulmonary function of stroke patients. J Phys Ther Sci. 2016 Jun;28(6):1896-900. doi: 10.1589/jpts.28.1896. Epub 2016 Jun 28. PubMed 27390442 ↗
  • Jung JH, Shim JM, Kwon HY, Kim HR, Kim BI. Effects of Abdominal Stimulation during Inspiratory Muscle Training on Respiratory Function of Chronic Stroke Patients. J Phys Ther Sci. 2014 Jan;26(1):73-6. doi: 10.1589/jpts.26.73. Epub 2014 Feb 6. PubMed 24567679 ↗
  • Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029. PubMed 21272713 ↗
  • Song GB, Park EC. Effects of chest resistance exercise and chest expansion exercise on stroke patients' respiratory function and trunk control ability. J Phys Ther Sci. 2015 Jun;27(6):1655-8. doi: 10.1589/jpts.27.1655. Epub 2015 Jun 30. PubMed 26180292 ↗
  • Shaw BS, Shaw I. Pulmonary function and abdominal and thoracic kinematic changes following aerobic and inspiratory resistive diaphragmatic breathing training in asthmatics. Lung. 2011 Apr;189(2):131-9. doi: 10.1007/s00408-011-9281-8. Epub 2011 Feb 12. PubMed 21318637 ↗
  • Belman MJ, Thomas SG, Lewis MI. Resistive breathing training in patients with chronic obstructive pulmonary disease. Chest. 1986 Nov;90(5):662-9. doi: 10.1378/chest.90.5.662. PubMed 3769566 ↗
  • Andersen JB, Dragsted L, Kann T, Johansen SH, Nielsen KB, Karbo E, Bentzen L. Resistive breathing training in severe chronic obstructive pulmonary disease. A pilot study. Scand J Respir Dis. 1979 Jun;60(3):151-6. PubMed 493905 ↗
  • Darnley GM, Gray AC, McClure SJ, Neary P, Petrie M, McMurray JJ, MacFarlane NG. Effects of resistive breathing on exercise capacity and diaphragm function in patients with ischaemic heart disease. Eur J Heart Fail. 1999 Aug;1(3):297-300. doi: 10.1016/s1388-9842(99)00027-6. PubMed 10935679 ↗
  • Soh JY, Lee SU, Lee I, Yoon KS, Song C, Kim NH, Sohn TS, Bae JM, Chang DK, Cha WC. A Mobile Phone-Based Self-Monitoring Tool for Perioperative Gastric Cancer Patients With Incentive Spirometer: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 19;7(2):e12204. doi: 10.2196/12204. PubMed 30777844 ↗
  • Tusman G, Bohm SH, Suarez-Sipmann F. Advanced Uses of Pulse Oximetry for Monitoring Mechanically Ventilated Patients. Anesth Analg. 2017 Jan;124(1):62-71. doi: 10.1213/ANE.0000000000001283. PubMed 27183375 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04636658
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
Feb 15, 2020
Primary completion
Aug 20, 2020
Completion
Sep 1, 2020
Last update
Nov 19, 2020

Study contacts

Anam Aftab, Phd*
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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