NCT04636658

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

October 3, 2020

Last Update Submit

November 15, 2020

Conditions

Keywords

strokeresistive diaphragmatic trainingpulmonary function

Outcome Measures

Primary Outcomes (4)

  • 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.

    4th week

  • 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.

    4th week

  • Oxygen level in blood

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

    4th week

  • Heart Rate

    Pulse oximetry is a test used to measure the heart rate

    4th week

Study Arms (2)

Incentive spirometer training

ACTIVE COMPARATOR

Incentive spirometer training

Other: Incentive spirometer training

diaphragmatic resistance exercises

EXPERIMENTAL

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

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

Incentive spirometer training

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

diaphragmatic resistance exercises

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location

Related Publications (21)

  • 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.

    PMID: 29791947BACKGROUND
  • 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.

    PMID: 19141505BACKGROUND
  • 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.

    PMID: 8910122BACKGROUND
  • 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.

    PMID: 27708464BACKGROUND
  • 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.

    PMID: 26505981BACKGROUND
  • 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.

    PMID: 27320833BACKGROUND
  • 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.

    PMID: 28736210BACKGROUND
  • 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.

    PMID: 29844210BACKGROUND
  • 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.

    PMID: 26519610BACKGROUND
  • 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.

    PMID: 8042521BACKGROUND
  • 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.

    PMID: 30154586BACKGROUND
  • 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.

    PMID: 27390442BACKGROUND
  • 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.

    PMID: 24567679BACKGROUND
  • 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.

    PMID: 21272713BACKGROUND
  • 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.

    PMID: 26180292BACKGROUND
  • 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.

    PMID: 21318637BACKGROUND
  • 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.

    PMID: 3769566BACKGROUND
  • 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.

    PMID: 493905BACKGROUND
  • 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.

    PMID: 10935679BACKGROUND
  • 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.

    PMID: 30777844BACKGROUND
  • 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.

    PMID: 27183375BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anam Aftab, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2020

First Posted

November 19, 2020

Study Start

February 15, 2020

Primary Completion

August 20, 2020

Study Completion

September 1, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations