NCT04358679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 20, 2020

Last Update Submit

April 20, 2020

Conditions

Spinal Cord Injuries

Keywords

Pulmonary FunctionSpinal Cord InjurySpirometryErgometer

Outcome Measures

Primary Outcomes (3)

  • Forced vital Capacity (FVC)

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

    6 Week

  • 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

    6 Week

  • 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.

    6 Week

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

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

Other: Conventional Treatment

Upper Limb ergometer training

EXPERIMENTAL

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

Other: Upper Limb ergometer training

Interventions

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

Conventional Treatment
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.

Upper Limb ergometer training

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • SCI at level of upper and lower thoracic spine

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paraplegic Center Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (12)

  • 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.

    PMID: 9160449BACKGROUND

  • 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.

    PMID: 22330108BACKGROUND

  • 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.

    PMID: 26169572BACKGROUND

  • 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).

    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.

    PMID: 19774306BACKGROUND

  • 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.

    PMID: 17482709BACKGROUND

  • 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.

    PMID: 18825160BACKGROUND

  • 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.

    PMID: 23416767BACKGROUND

  • 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.

    PMID: 29434464BACKGROUND

  • 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.

    PMID: 28710067BACKGROUND

  • 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.

    PMID: 26259052BACKGROUND

  • 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.

    PMID: 16738459BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Iqbal Tariq, MsCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

September 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 10, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)