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Spinal Cord InjuriesNCT04358679

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

A study testing Conventional Treatment and Upper Limb ergometer training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized Control Trial, To determine the effects of arm ergometer exercise on pulmonary function of Spinal Cord Injury. Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Conventional Treatment and Upper Limb ergometer training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Sep 2019to 10 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • SCI at level of upper and lower thoracic spine

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Paraplegic Center Peshawar

    Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

Official title: Effects of Upper Limb Ergometer on Pulmonary Function Among Patients With Spinal Cord Injury.

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

Read the detailed description

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.

Being tested
Conventional Treatment, Upper Limb ergometer training
Keywords
Pulmonary Function, Spinal Cord Injury, Spirometry, Ergometer
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional TreatmentOther

    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 trainingOther

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

Study groups in NCT04358679
Study groupRoleWhat they receive
Conventional TreatmentActive comparatorConventional Treatment: Deep breathing, Assisted coughing, Sustained stretching, Splinting, Bracing and Functional mobility
Receives: Other: Conventional Treatment
Upper Limb ergometer trainingExperimentalConventional Treatment + Upper Limb (UL) ergo-meter exercise
Receives: Other: Upper Limb ergometer training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced vital Capacity (FVC)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

    Measured: 6 Week

  2. Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    Measured: 6 Week

  3. Peak Expiratory Flow (PEF)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.

    Measured: 6 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start1 Sep 2019
  3. Primary completion30 Dec 2019
  4. Study completion10 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04358679
Sponsor's protocol ID
REC/00592 Somia Ilyas
Status last verified
Apr 2020
First submitted
20 Apr 2020
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9160449

  • 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.

    PubMed 22330108

  • 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.

    PubMed 26169572

  • 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).

  • 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.

    PubMed 19774306

  • 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.

    PubMed 17482709

  • 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.

    PubMed 18825160

  • 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.

    PubMed 23416767

  • 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.

    PubMed 29434464

  • 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.

    PubMed 28710067

  • 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.

    PubMed 26259052

  • 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.

    PubMed 16738459

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Treatment and Upper Limb ergometer training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced vital Capacity (FVC) (time frame: 6 Week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04358679, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.

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