Upper Limb Ergometer on Pulmonary Function Among Patients With Spinal Cord Injury.

NCT ID: NCT04358679

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-01-10

Brief Summary

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Randomized Control Trial, To determine the effects of arm ergometer exercise on pulmonary function of Spinal Cord Injury.

Detailed Description

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The spinal cord is a tubular structure contained nervous tissue. This acts as a transmission channel of nerve signals within the brain and spinal cord. It contains grey and white matter. The grey matter consists of cell bodies of different sensory and motor neurons and white matter consists of oriented spinal tracts.

By 2007, a prospective observational study had been conducted after a disaster occurred in Pakistan which was the most cataclysmic natural disaster in country's history as a result 73000 people were lost their lives and 126000 were harmed. There was no Spinal Cord Injury (SCI) registry existed in the country but according to different estimates 650-750 had been effected of SCI.

In United States SCI incidence mainly due to higher percentage of violence-related SCIs (18%)which is higher compared to the western Europe (8%) Australia (2%). In Pakistan the most common traumatic cause of SCI was falling from different cause followed by road traffic accident (RAT) (25.2%) and functional aerobic impairment (FAI) (8.4%). The way that SCI is associated with fantastic expenses and human sufferings , yet careful statistics of SCI are not accessible in dominant of developing countries including Pakistan.

Total lung capacities become abnormal in chronic spinal cord injury patients. Changes in chest wall compliance and decreased respiratory muscle strength leads to abnormal changes in overall lung capacities.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Treatment

Conventional Treatment: Deep breathing, Assisted coughing, Sustained stretching, Splinting, Bracing and Functional mobility

Group Type ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type OTHER

Conventional Treatment:

* Deep breathing: 10-15 reps, twice a day (BD)
* Assisted coughing 10-15 reps, BD
* range of motion (ROM)+ stretching 10 reps, BD
* Tilt table standing

Upper Limb ergometer training

Conventional Treatment + Upper Limb (UL) ergo-meter exercise

Group Type EXPERIMENTAL

Upper Limb ergometer training

Intervention Type OTHER

Conventional Treatment + upper limb (UL) ergometry exercise UL ergometry exercise 15 to 20 mints , 2 times ,five days per week for 6 weeks.

Interventions

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Conventional Treatment

Conventional Treatment:

* Deep breathing: 10-15 reps, twice a day (BD)
* Assisted coughing 10-15 reps, BD
* range of motion (ROM)+ stretching 10 reps, BD
* Tilt table standing

Intervention Type OTHER

Upper Limb ergometer training

Conventional Treatment + upper limb (UL) ergometry exercise UL ergometry exercise 15 to 20 mints , 2 times ,five days per week for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* SCI at level of upper and lower thoracic spine

Exclusion Criteria

* Cardiovascular diseases
* Active inflammation or infection going in body
* Malignancies
* Those Individuals with have psychiatric disorders
* Any other neurological condition related to brain (stroke, parkinson's etc)
* Pressure ulcers (grade 3 and grade 4)
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iqbal Tariq, MsCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Paraplegic Center Peshawar

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

References

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Maynard FM Jr, Bracken MB, Creasey G, Ditunno JF Jr, Donovan WH, Ducker TB, Garber SL, Marino RJ, Stover SL, Tator CH, Waters RL, Wilberger JE, Young W. International Standards for Neurological and Functional Classification of Spinal Cord Injury. American Spinal Injury Association. Spinal Cord. 1997 May;35(5):266-74. doi: 10.1038/sj.sc.3100432. No abstract available.

Reference Type BACKGROUND
PMID: 9160449 (View on PubMed)

Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.

Reference Type BACKGROUND
PMID: 22330108 (View on PubMed)

Terson de Paleville D, Lorenz D. Compensatory muscle activation during forced respiratory tasks in individuals with chronic spinal cord injury. Respir Physiol Neurobiol. 2015 Oct;217:54-62. doi: 10.1016/j.resp.2015.07.001. Epub 2015 Jul 11.

Reference Type BACKGROUND
PMID: 26169572 (View on PubMed)

Arsh A, Darain H, Haq ZU, Zeb A, Ali I, Ilyas SM. Epidemiology of spinal cord injuries due to bomb blast attacks, managed at paraplegic centre peshawar, pakistan: a nine years retrospective study. KMUJ: KHYBER MEDICAL UNIVERSITY JOURNAL. 2017;9(2).

Reference Type BACKGROUND

Postma K, Bussmann JB, Haisma JA, van der Woude LH, Bergen MP, Stam HJ. Predicting respiratory infection one year after inpatient rehabilitation with pulmonary function measured at discharge in persons with spinal cord injury. J Rehabil Med. 2009 Sep;41(9):729-33. doi: 10.2340/16501977-0410.

Reference Type BACKGROUND
PMID: 19774306 (View on PubMed)

Devillard X, Rimaud D, Roche F, Calmels P. Effects of training programs for spinal cord injury. Ann Readapt Med Phys. 2007 Jul;50(6):490-8, 480-9. doi: 10.1016/j.annrmp.2007.04.013. Epub 2007 Apr 24. English, French.

Reference Type BACKGROUND
PMID: 17482709 (View on PubMed)

Kloosterman MG, Snoek GJ, Jannink MJ. Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. Spinal Cord. 2009 Mar;47(3):196-203. doi: 10.1038/sc.2008.113. Epub 2008 Sep 30.

Reference Type BACKGROUND
PMID: 18825160 (View on PubMed)

Postma K, Haisma JA, de Groot S, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Changes in pulmonary function during the early years after inpatient rehabilitation in persons with spinal cord injury: a prospective cohort study. Arch Phys Med Rehabil. 2013 Aug;94(8):1540-6. doi: 10.1016/j.apmr.2013.02.006. Epub 2013 Feb 14.

Reference Type BACKGROUND
PMID: 23416767 (View on PubMed)

Torhaug T, Brurok B, Hoff J, Helgerud J, Leivseth G. Arm Cycling Combined with Passive Leg Cycling Enhances VO2peak in Persons with Spinal Cord Injury Above the Sixth Thoracic Vertebra. Top Spinal Cord Inj Rehabil. 2018 Winter;24(1):86-95. doi: 10.1310/sci17-00029. Epub 2017 Nov 20.

Reference Type BACKGROUND
PMID: 29434464 (View on PubMed)

DeVeau KM, Harman KA, Squair JW, Krassioukov AV, Magnuson DSK, West CR. A comparison of passive hindlimb cycling and active upper-limb exercise provides new insights into systolic dysfunction after spinal cord injury. Am J Physiol Heart Circ Physiol. 2017 Nov 1;313(5):H861-H870. doi: 10.1152/ajpheart.00046.2017. Epub 2017 Jul 14.

Reference Type BACKGROUND
PMID: 28710067 (View on PubMed)

West CR, Currie KD, Gee C, Krassioukov AV, Borisoff J. Active-Arm Passive-Leg Exercise Improves Cardiovascular Function in Spinal Cord Injury. Am J Phys Med Rehabil. 2015 Nov;94(11):e102-6. doi: 10.1097/PHM.0000000000000358.

Reference Type BACKGROUND
PMID: 26259052 (View on PubMed)

Zhan S, Cerny FJ, Gibbons WJ, Mador MJ, Wu YW. Development of an unsupported arm exercise test in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2006 May-Jun;26(3):180-7; discussion 188-90. doi: 10.1097/00008483-200605000-00013.

Reference Type BACKGROUND
PMID: 16738459 (View on PubMed)

Other Identifiers

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REC/00592 Somia Ilyas

Identifier Type: -

Identifier Source: org_study_id

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