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The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients

The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04822831
Enrollment
60
Registered
2021-03-30
Start date
2017-05-30
Completion date
2018-07-30
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intubation, Exercise, Mechanical Ventilation, Position

Brief summary

Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in Respiratory care wards (RCWs). This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in respiratory care ward in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day. There were 29 prolonged mechanical ventilation (PMV) patients in the experimental group and 26 in the control group. Our conclusions showed that PMV patients can significantly improve the maximum inspiratory pressure (MIP) in the post-test while performed a 45-degree semi-sitting position with upper limb training for 4 weeks. The minute ventilation (MV) has a trend of increasing month by month in the experimental group, but it is necessary to consider whether it is due to the improvement of lung function or just cause of the increased oxygen consumption and accelerated respiratory rate, so it can not be inferred to improvement of the patient's condition or lung function.

Detailed description

Background: Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years. However, the high cost shows the high morbidity rate, high mortality rate and low ventilator weaning rate of prolonged mechanical ventilation patients, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in the respiratory care ward (RCW). OBJECTIVE: To investigate the improvement of respiratory function and the effect of respirator detachment in 45-degree semi-sitting and upper limb training, and to understand the correlation between this training activity and death risk. METHODS: This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in the respiratory care ward (RCW) in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2hrs and upper-limb exercise training 10mins once a day. After 4 weeks, the investigators measure the respiratory parameters such as the maximum inspiratory pressure (MIP), the tidal volume (VT), the minute ventilation (MV), and the rapid shallow breathing index(RSBI) of these two groups, and used the generalized estimating equation (GEE) to compare with them.

Interventions

BEHAVIORAL45 Degree Semi-recumbent Position With Upper Limb Exercise Training

The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day, and this intervention kept 4 weeks.

BEHAVIORALno 45 Degree Semi-recumbent Position With Upper Limb Exercise Training

The control group was with usual treatment.

Sponsors

Taoyuan General Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The participants involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.

Intervention model description

This study used repeated experimental measurements and purpose sampling, and we invited patients in respiratory care ward (RCW) in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting for 2hrs and upper-limb exercise training 10mins once a day. The control group was just continue the routine treatment. After 4 weeks, we measure the respiratory parameters such as maximum inspiratory pressure (MIP), tidal volume (VT), minute ventilation (MV), and rapid shallow breathing index(RSBI) of these two groups, and used GEE to compare with them. To find the differences in respiratory parameters, ventilator detachment rate,

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* respiratory care ward (RCW) cases using mechanical ventilators * 20 years old ≦ age ≦ 89 years old * Those who used antibiotics without infection and fever (body temperature \>38.5℃) in the past 3 days * the fraction of inspiration O2(FiO2)≦50% and the positive end expiratory pressure(PEEP)≦10 * 90 mm-Hg≦ systolic blood pressure(SBP) ≦160 mm-Hg * 60 beats/min≦ heart rate(HR) ≦130 beats/min without arrhythmia * 12 times/min≦ respiratory rate(RR) ≦35 times/min * 90%≦ oxygen saturation by pulse oximetry (SPO2) ≦100% * Patients with spontaneous breathing * Digestible without continuous feeder

Exclusion criteria

* respiratory care ward (RCW) cases without mechanical ventilators * Age \<20 years old or age\>89 years old * Those who have been infected with fever in the past 3 days (body temperature \>38.5℃) and are taking antibiotic * the fraction of inspiration O2(FiO2) \>50% and the positive end expiratory pressure(PEEP)\>10 * systolic blood pressure(SBP)\< 90 mm-Hg or systolic blood pressure(SBP) \>160 mm-Hg * heart rate(HR)\<60 beats/min or heart rate(HR)\>130 beats/min and arrhythmia * respiratory rate(RR)\<12 times/minute or respiratory rate(RR)\>35 times/minute * oxygen saturation by pulse oximetry (SPO2) \<90% * Patients without spontaneous breathing * Poor digestion and use of continuous feeders

Design outcomes

Primary

MeasureTime frameDescription
maximum inspiratory pressure (MIP)Change from maximum inspiratory pressure (MIP) at 1 monthAfter doing intervention for 4 weeks, we measure the maximum inspiratory pressure (MIP) of these two groups
tidal volume (VT)Change from tidal volume (VT) at 1 monthAfter doing intervention for 4 weeks, we measure the tidal volume (VT) of these two groups
minute ventilation (MV)Change from minute ventilation (MV) at 1 monthAfter doing intervention for 4 weeks, we measure the minute ventilation (MV) of these two groups
rapid shallow breathing index (RSBI)Change from rapid shallow breathing index (RSBI) at 1 monthAfter doing intervention for 4 weeks, we measure the rapid shallow breathing index (RSBI) of these two groups

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026