Validation of an Intermittent Shuttle Walking Protocol in Patients With COPD

NCT04326855 | Unknown

• 1 other identifier: 280032
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the UK, field-based walking is prescribed in the pulmonary rehabilitation (PR) setting as a convenient, less resource-intensive, and highly responsive exercise modality in COPD patients. However, endurance time during the implementation of field-based walking protocols, such as the endurance shuttle walking (ESW) protocol, is limited to only a few minutes secondary to intense exertional symptoms. It therefore seems sensible to develop an intermittent field-based walking protocol that would prolong endurance time and walking distance compared to the commonly implemented in the PR setting continuous ESW protocol. The aim of this study is three-fold: 1) to identify whether an intermittent shuttle walking protocol significantly prolongs walking distance compared to the widely implemented continuous ESW protocol in the PR setting in patients with advanced COPD; 2) to investigate the test re-test reliability of the distance walked during the intermittent shuttle walking protocol; and 3) to explore patients' and health care professionals' experiences of implementing the intermittent walking protocol and the perceived factors affecting the implementation of these protocols in the PR setting. The study hypothesis is that the intermittent shuttle walking protocol would be associated with lower dynamic hyperinflation and breathlessness, thereby facilitating an increase in walking distance compared to the continuous ESW protocol. The same group of patients with advanced COPD will initially perform an incremental shuttle walk test (ISWT) (visit 1) to establish peak walking speed and subsequently patients will perform the continuous ESW protocol (visit 2) at a walking speed corresponding to 85% of peak walking speed to the limit of tolerance. On two additional visits (visits 3 and 4) patients will perform two intermittent shuttle walking protocols to the limit of tolerance by alternating 1-min walking bouts at a walking speed corresponding to 85% peak walking speed (equivalent to the ESW protocol) with 1-min rest periods in between walking bouts to establish the reproducibility of this protocol. Focus group interviews with patients and healthcare professionals will be conducted to explore perceptions of undertaking and implementing, respectively the intermittent walking protocol.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Chronic Obstructive Lung Disease; COPD

Outcome Measures

Primary Outcomes (1)

• Change in Walking distance

  Distance walked during the intermittent shuttle walking protocol compared to the distance walked during the continuous endurance shuttle walking protocol assessed in meters. Change in walking distance covered during the intermittent walking protocol.

  The intervention will be performed within 30 days from the date of patient recruitment. Outcome 1 will be assessed at the 20th minute for the intermittent walking protocol.

Secondary Outcomes (5)

• Change in Peak oxygen consumption (VO2 peak)

  The intervention will be performed within 30 days from the date of patient recruitment.Outcome 2 will be assessed at the 20th minute for the intermittent walking protocol.

• Change in Cardiac output

  The intervention will be performed within 30 days from the date of patient recruitment.Outcome 3 will be assessed at the 20th minute for the intermittent walking protocol.

• Change in Exertional Symptoms (breathlessness and leg discomfort)

  The intervention will be performed within 30 days from the date of patient recruitment.Outcome 4 will be assessed at the 20th minute for the intermittent walking protocol.

• Change in Minute Ventilation

  The intervention will be performed within 30 days from the date of patient recruitment.Outcome 5 will be assessed at the 20th minute for the intermittent walking protocol.

• Change in Inspiratory Capacity

  The intervention will be performed within 30 days from the date of patient recruitment. Outcome 6 will be assessed at the 20th minute for the intermittent walking protocol.

Study Arms (1)

20 patients with advanced COPD

EXPERIMENTAL

This will be a cross sectional observational study. COPD patients will be recruited from those referred to the Pulmonary Rehabilitation programme at RVI Hospital in Newcastle upon Tyne. Potentially eligible patients will be identified by the physiotherapy team within the Trust, who will provide initial information about the study. Delegated investigators will confirm eligibility and discuss full details of the trial. Patients will be given time to consider participation in the trial before written informed consent is obtained.

Other: Incremental shuttle walking protocol (ISWT); Other: Endurance shuttle walking (ESW) protocol; Other: First Intermittent shuttle walking protocol; Other: Second Intermittent shuttle walking protocol; Other: Focus group study

Interventions

Incremental shuttle walking protocol (ISWT) OTHER

Patients will perform an incremental shuttle walk test to the limit of tolerance to establish peak walking speed. The test will be developed in a 10-m course corridor, and it will be externally-paced via a recorded metronome that gives a signal for each stride. The walking pace will be increased every minute and the test will be terminated when the individual is no longer able to keep up the pace. Pulmonary variables will be recorded breath-by-breath. Cardiac output will be assessed every min. Arterial oxygen saturation will be measured by a pulse oximeter. Patients will score the intensity of their breathlessness and leg discomfort using the 1-10 Borg's scale every minute.

20 patients with advanced COPD

Endurance shuttle walking (ESW) protocol OTHER

Subsequently, during the second visit all patients will perform the continuous endurance shuttle walk (ESW) protocol to the limit of tolerance at a walking speed corresponding to 85% of VO2 peak derived by the ISWT (visit 1). During the ESW protocol patients will receive standardized instructions to walk for as long as possible although there will be a predetermined 6 minute maximum point. No further encouragement will be provided during the exercise performance. The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms. Gas exchange and cardiorespiratory variables will be assessed as per visit 1.

20 patients with advanced COPD

First Intermittent shuttle walking protocol OTHER

All patients will perform an intermittent shuttle walking protocols to the limit of tolerance (visit 3) by alternating 1-min walking bouts sustained at a walking speed equivalent to 85% peak (equivalent to the continuous ESW protocol) with 1-min rest periods.The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms although there will be a predetermined 20 minute maximum point.Gas exchange and cardiorespiratory variables will be assessed as per visit 1.

20 patients with advanced COPD

Second Intermittent shuttle walking protocol OTHER

To obtain test re-test reliability in terms of distance walked, of cardiorespiratory and symptoms responses this intermittent shuttle walking protocol will be repeated on a different day (visit 4). The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms although there will be a predetermined 20 minute maximum point. Gas exchange and cardiorespiratory variables will be assessed as per visit 1.

Also known as: Test-retest reliability study

20 patients with advanced COPD

Focus group study OTHER

Semi-structured interviews to explore patients' preferences of undertaking the intermittent or continuous ESW protocols and healthcare professionals' perceived factors affecting the implementation of these protocols in the PR setting. These semi-structured interviews consist of questions in some degree predetermined order but still ensures flexibility in the way issues are addressed to the patients. Conversation is sustained in an informal tone and lasts for about an hour. Participants are allowed for an open response in their own words.

Also known as: Semi-structured Interviews

20 patients with advanced COPD

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40 years or older.
• Current or previous smoking history: 10 or more pack years.

You may not qualify if:

• Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
• Moderate or severe COPD exacerbation within 6 weeks.
• Unstable cardiac arrhythmia.
• Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
• Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.

Sponsors & Collaborators

• Northumbria University: lead
• Royal Victoria Infirmary: collaborator

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Charikleia Alexiou, B.Sc. M.Sc.

CONTACT

07547942172; charikleia.alexiou@northumbria.ac.uk

Ioannis Vogiatzis, Professor

CONTACT

01913495446; ioannis.vogiatzis@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cross sectional interventional trial. The same group of COPD patients will perform four shuttle walking protocols. The intermittent shuttle walking protocol will be compared to the endurance shuttle walking protocol (control) which is commonly implemented in the PR settings. The intermittent shuttle walking protocol will be performed twice by all patients to obtain test re-test reliability in terms of distance walked, of cardiorespiratory and symptoms responses. The order of testing will be determined by balanced sequence.

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 30, 2020
• Study Start: October 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: March 30, 2020

Record last verified: 2020-03