Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients

NCT ID: NCT05425238

Last Updated: 2023-07-20

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2022-12-15

Brief Summary

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This study is conducted to investigate the effects of low load Blood Flow Resistance exercise to improve strength and transfer in lower cervical spinal cord injury patientsCervical Spinal Cord injury patients have very less window of opportunity towards functional mode of life. In complete cervical spinal cord injuries only few muscles of upper limb are completely innervated and it is a need to gain maximum output and advantage out of that. Through conventional strength training it is possible to make him do unsupported sitting and transfer But with BFR-RE it may have a possibility to do this procedure in less time than the conventional strength training and patient will save cost of hospital stay as he may timely discharge from hospital early

Detailed Description

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Conditions

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Cervical Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Blood flow restriction

Resistance training protocol but with Blood flow restriction technique Standard BFR Application: a standard pressure (used for all patients) for e.g. 180 mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type OTHER

strengthening protocol but with Blood flow restriction technique

.Standard BFR Application: a standard pressure (used for all patients) for e.g. 180

mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.40% cuff pressure as percentage of LOP.(4) And performing BFR-RE with low load exercises. So 30% of 1 RPM would be enough 4 times a week for 6 week

Conventional physical therapy

Resistance training to stimulate skeletal muscle hypertrophy and strength adaptations in Duration of 6 weeks

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type OTHER

Resistance exercise 75 repetitions across four sets of exercises, with30 repetitions in the first set and 15 repetitions in each subsequent set. 4 times a week for 6

Interventions

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Blood flow restriction

strengthening protocol but with Blood flow restriction technique

.Standard BFR Application: a standard pressure (used for all patients) for e.g. 180

mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.40% cuff pressure as percentage of LOP.(4) And performing BFR-RE with low load exercises. So 30% of 1 RPM would be enough 4 times a week for 6 week

Intervention Type OTHER

Conventional physical therapy

Resistance exercise 75 repetitions across four sets of exercises, with30 repetitions in the first set and 15 repetitions in each subsequent set. 4 times a week for 6

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Both male and female, with age between 16-50 years.
* Patients evaluated with C6 to C8 tetraplegic complete injury.
* Patients classified in ASIA A, ASIA B.
* At least Muscle grading of grade 2.
* Patients with sub-acute, chronic stage.

Exclusion Criteria

* Patients with other neurologic conditions, orthopedic problems, and uncontrolled metabolic diseases.
* Patients with muscles strength grading of less than 2.
* Undergone nerve transfer surgery.
* Patients with acute stage.
* History of DVT.
* Patients who are already performing structured physical activities such as muscle Strengthening exercises.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 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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Binash Afzal, PHD*

Role: PRINCIPAL_INVESTIGATOR

Riphah international university lahore campus

Locations

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Lahore general Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.

Reference Type BACKGROUND
PMID: 27815685 (View on PubMed)

Kozlowski AJ, Heinemann AW. Using individual growth curve models to predict recovery and activities of daily living after spinal cord injury: an SCIRehab project study. Arch Phys Med Rehabil. 2013 Apr;94(4 Suppl):S154-64.e1-4. doi: 10.1016/j.apmr.2012.11.050.

Reference Type BACKGROUND
PMID: 23527771 (View on PubMed)

Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.

Reference Type BACKGROUND
PMID: 21922259 (View on PubMed)

Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.

Reference Type BACKGROUND
PMID: 28259850 (View on PubMed)

Yasuda T, Fukumura K, Iida H, Nakajima T. Effect of low-load resistance exercise with and without blood flow restriction to volitional fatigue on muscle swelling. Eur J Appl Physiol. 2015 May;115(5):919-26. doi: 10.1007/s00421-014-3073-9. Epub 2014 Dec 10.

Reference Type BACKGROUND
PMID: 25491331 (View on PubMed)

Anderson K, Aito S, Atkins M, Biering-Sorensen F, Charlifue S, Curt A, Ditunno J, Glass C, Marino R, Marshall R, Mulcahey MJ, Post M, Savic G, Scivoletto G, Catz A; Functional Recovery Outcome Measures Work Group. Functional recovery measures for spinal cord injury: an evidence-based review for clinical practice and research. J Spinal Cord Med. 2008;31(2):133-44. doi: 10.1080/10790268.2008.11760704.

Reference Type BACKGROUND
PMID: 18581660 (View on PubMed)

Perwaiz S, Afzal MW, Fatima G. Comparison between qualitative and quantitative measurement of strength deficit in shoulder flexors of young females: A cross- sectional study. J Pak Med Assoc. 2021 Nov;71(11):2559-2562. doi: 10.47391/JPMA.011431.

Reference Type BACKGROUND
PMID: 34783737 (View on PubMed)

Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

Reference Type BACKGROUND
PMID: 31156448 (View on PubMed)

Tuncali B, Karci A, Tuncali BE, Mavioglu O, Ozkan M, Bacakoglu AK, Baydur H, Ekin A, Elar Z. A new method for estimating arterial occlusion pressure in optimizing pneumatic tourniquet inflation pressure. Anesth Analg. 2006 Jun;102(6):1752-7. doi: 10.1213/01.ane.0000209018.00998.24.

Reference Type BACKGROUND
PMID: 16717321 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/22/0222

Identifier Type: -

Identifier Source: org_study_id

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