The Effect of Neck Stabilization Exercise Plus Cardiopulmonary Rehabilitation on Pulmonary Function of SCI

NCT04500223 | Completed

• 1 other identifier: TYGH108045
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance training have been widely implemented in clinical practice for curing chronic neck pain. By means of CCFE, the muscle balance between deep neck flexor and superficial flexor would be optimal during neck movement. In other words, the superficial neck flexor( scalenes, SCM, and trapezius) would not overactive and the fatigue threshold might increase. Superficial neck flexor endurance training is proved to be efficient in reducing superficial cervical flexor muscle fatigue as well as increasing cervical flexion strength. Reasonably, Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance training are also beneficial to pulmonary function due to training the respiratory accessory muscle (scalens and SCM). Hence this article hypothesizes that Cervicocranial flexion exercise (CCFE) and superficial neck flexor endurance training combined with common pulmonary rehabilitation will manifest better outcomes (pulmonary function, dyspnea situation, pain and stiffness level of neck) than pulmonary rehabilitation only.

Conditions

Spinal Cord Injury

Keywords

Cervical exercise; Cardiopulmonary rehabilitation; Pulmonary function

Outcome Measures

Primary Outcomes (3)

• FVC change

  liter

  initial points, first week, second week, final points.(total 3 week)

• FEV1/FVC change

  percentage

  initial points, first week, second week, final points.(total 3 week)

• Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) score change

  points

  initial points, first week, second week, final points.(total 3 week)

Study Arms (2)

Cervical Cranioflexion exercise plus cardiopulmonary exercise

EXPERIMENTAL

subjects who received Cervical Cranioflexion exercise plus cardiopulmonary exercise

Other: Cervical Cranioflexion exercise plus cardiopulmonary exercise

Cervical stretch exercise plus cardiopulmonary rehabilitation

ACTIVE COMPARATOR

subjects who received Cervical stretch exercise plus cardiopulmonary rehabilitation

Other: Cervical stretch exercise plus cardiopulmonary rehabilitation

Interventions

Cervical Cranioflexion exercise plus cardiopulmonary exercise OTHER

Intervention:Cervical Cranioflexion exercise plus cardiopulmonary exercise

Cervical Cranioflexion exercise plus cardiopulmonary exercise

Cervical stretch exercise plus cardiopulmonary rehabilitation OTHER

control:Cervical stretch exercise plus cardiopulmonary rehabilitation

Cervical stretch exercise plus cardiopulmonary rehabilitation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCI onset in a year.
• Motor level above T12 and American Spinal Injury Association Impairment Scale (AIS) grade A, B, C, or D.
• Age from 20\~70.
• FEV1\< 80% prediction value.

You may not qualify if:

• Ventilation dependent
• Tracheostomy
• Psychiatric condition
• Progressive diseases
• infection
• Cancer
• Unable to speak Chinese or English.

Sponsors & Collaborators

• Taoyuan General Hospital: lead

Study Sites (1)

Taoyaun General Hospital, Ministry of Wealth and Health

Taoyuan District, Taoyuan Dist., 330, Taiwan

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: August 5, 2020
• Study Start: April 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 28, 2021
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)