The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery

NCT02757092 | Completed Results DMC

• 1 other identifier: 1046659A3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The advantages of thoracoscopic surgery include smaller wounds, fewer postoperative complications, and shortened hospital stay. However,complications such as pain, pulmonary function insufficiency, pneumonia,postoperative pneumothorax, persistent air leakage, subcutaneous emphysema, cough, and hemoptysis may occur in older patients after thoracoscopic surgery. Pulmonary rehabilitation has been demonstrated by evidence-base medicine could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery. Studies have suggested that pulmonary rehabilitation should be performed for at least 4 weeks to optimize the training effect .However, most patients who undergo thoracoscopic surgery were discharged within 3-5 days. Such a short hospital stay impeded the delivery of pulmonary rehabilitation. Home-based pulmonary rehabilitation appeared to be an option for these patients The purpose of this study is to determine whether Pulmonary rehabilitation are effective on patients who had thoracic surgeries.

Conditions

Lung Neoplasms

Keywords

Pulmonary rehabilitation; surgery; exercise

Outcome Measures

Primary Outcomes (3)

• Discharge 2weeks Exercise Capacity

  Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.

  assessed at discharge 2weeks

• Discharge 6 Weeks Exercise Capacity

  Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.

  assessed at discharge.6weeks

• Discharge 12 Weeks Exercise Capacity

  Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome.

  assessed at discharge 12 weeks

Secondary Outcomes (27)

• Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)

  assessments at 2 weeks after discharge

• Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)

  assessed at 2 weeks after discharge

• Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)

  assessed at discharge 2weeks

• Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)

  assessed at discharge 2weeks

• Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)

  assessed at discharge 2 weeks.

Study Arms (2)

Home-based rehabilitation program

EXPERIMENTAL

0-2 weeks,1. aerobic exercise intensity was targeted to reach 10-11 points of perceived exercise (RPE) scale 2. raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min 3.walked at a comfortable speed for 15 min twice per day.4. Triflo-II was performed 8-10 times per hour. inspiratory muscle training with the initial pressure set at 25%-30% of the maximum inspiratory pressure.3-6 weeks, aerobic exercise reach 12-15 points on the RPE scale. upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day , walking exercise for a total of 30 min. Triflo-II was performed 8-10 times per hour, and train the inspiratory muscle with the pressure intensity adjusted to more than 5% of that in the first stage.

Other: Home-based Pulmonary Rehabilitation

standard care

ACTIVE COMPARATOR

control group accept the pulmonary rehabilitation (breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation.

Other: Home-based Pulmonary Rehabilitation

Interventions

Home-based Pulmonary Rehabilitation OTHER

(1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.

Home-based rehabilitation program; standard care

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Signed consent
• The men and women over the age of 65
• admission to undergo VATS.
• consciousness and ability to communicate
• ability to undergo 6 weeks of a home-based pulmonary rehabilitation program

You may not qualify if:

• refusal to participate
• unplanned emergency surgery
• hemodynamic instability
• received other surgery within a month postsurgery
• unconsciousness after surgery
• bedridden and upper or lower limb weakness
• received radiation and chemotherapy postsurgery
• implementation of thoracoscopic surgery for biopsy only

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung Memorial Hospital

Kaohsiung City, Niaosong, 83342, Taiwan

Location

Chang Gung Memorial Hospital

Kaohsiung City, 83342, Taiwan

Location

MeSH Terms

Conditions

Lung Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Limitations and Caveats

First,sample size is low,this may affect the result of the study;secondly, pulmonary function should collect DLCO and MVV;third,although the patients were checked via telephone every week,there is no surefire way to enforce intervention.

Results Point of Contact

• Title: Respiratory therapist Nai-Ying Kuo
• Organization: Chang Gung Memorial Hospital

ellen0605@gmail.com

+886077317123

Study Officials

• Jui Fang Liu, PhD

  Department of Respiratory Therapy

  STUDY DIRECTOR

• Nai Ying Kuo, master

  Department of Respiratory Therapy

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory therapist

Model Details: This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in patients after thoracoscopy. After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge. The random assignment was performed based on simple randomization by using numbers from 1 to 36; numbered, sealed, opaque envelopes were used for allocation concealment. These envelopes were randomly distributed by non researchers and recorded.

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 29, 2016
• Study Start: March 31, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 31, 2017
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: connect with miss Nai ying kuo and Share IPD by email

Locations

TW (2)