Feasibility of Interval Exercise in Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Step and walk-based high intensity interval exercise
Sponsored by
About this trial
This is an interventional other trial for Bronchiectasis
Eligibility Criteria
Inclusion Criteria:
- Male or female adults (i.e. >18 years)
- Clinical diagnosis of non-cystic fibrosis bronchiectasis.
- Registered/treated as an inpatient or outpatient with the United Lincolnshire NHS Trust
- Capable of giving informed consent.
- Deemed eligible for pulmonary rehabilitation (including exercise) by clinical specialist, specialist nurse, or respiratory physiotherapist.
- Has not met national guidelines for exercise engagement during the preceding 3 months (i.e. completing at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity each week).
Exclusion Criteria:
- Inability or unwillingness to sign informed consent;
- Outside of stated age range (i.e. <18 years);
- Pregnant;
- Suffering from any major co-morbidity known to impair exercise tolerance (i.e. heart failure/disease, diabetes, neuromuscular and/or musculoskeletal disease or injury) or another factor considered as a contraindication to clinical exercise testing by clinical specialist respiratory physiotherapist;
- Has met national guidelines for exercise engagement during the previous 3 months (i.e. completing at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity each week)
Sites / Locations
- Lincoln County Hospital Physiotherapy Unity
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High intensity interval exercise
Arm Description
Completion of four separate step and walk-based high intensity interval exercise sessions, followed by completion of six week unsupervised (at home) high intensity interval exercise intervention
Outcomes
Primary Outcome Measures
Completion rate
Completion rate (%) for each type of interval exercise protocol administered
Emergent adverse events
Number of adverse events (count) during high-intensity interval exercise protocols
Secondary Outcome Measures
Heart rate
Mean and peak heart rate values (beats per minute)
Oxygen consumption
Mean and peak oxygen consumption values (millilitres per kilogram per minute)
Minute ventilation
Mean and peak minute ventilation values (litres per minute)
Respiratory frequency
Mean and peak respiratory frequency values (breaths per minute)
Oxygen saturation
Mean and peak oxygen saturation values (% SpO2)
Perceived fatigue during interval exercise
Fatigue [Borg CR 0-10 Scale]
Perceived breathlessness during interval exercise
Perceived Breathlessness [Borg CR 0-10 Scale]
Affect/Pleasure response to interval exercise
Affect/Pleasure [Feeling Scale -5 to +5 Score]
Six-Minute Walk Test Performance
Six-Minute Walk Test (distance in meters)
Chester Step Test Performance
Chester Step Test (final step rate in steps per minute)
Quadriceps Strength
Isometric Quadriceps Strength Test (peak force [kg/N])
Patient perceptions of interval exercise protocols
Interview questions
EuroQoL (EQ-5D-5L) questionnaire for health-related quality of life
EuroQoL (EQ-5D-5L) questionnaire for health-related quality of life: 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels
Exacerbations and/or adverse events during interval exercise
Event based, patient reported
Full Information
NCT ID
NCT03920124
First Posted
October 5, 2018
Last Updated
September 26, 2019
Sponsor
University of Lincoln
Collaborators
United Lincolnshire Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03920124
Brief Title
Feasibility of Interval Exercise in Bronchiectasis
Official Title
Exploring the Feasibility and Effectiveness of Minimal-equipment High-intensity Interval Exercise (HIIE) Interventions in Bronchiectasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lincoln
Collaborators
United Lincolnshire Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Research to date suggests that encouraging increased physical activity and exercise engagement may be an effective way to improve symptoms, fitness, quality of life, and reduce time spent in hospital for bronchiectasis sufferers. However, relatively few patients continue to engage with exercise programs that are of benefit to their health and symptoms. Barriers to exercise are thought to include time constraints and the use of specialist equipment (e.g. cycle ergometers) which may not be available or accessible in the home (or hospital) setting. With these points in mind, there is growing interest in brief, relatively intense, interval exercise interventions for chronic lung disease sufferers as they require minimal equipment and may more easily translate back into the home setting. Of the types of approach this might include, both stair-based and walk-based interval exercise appear to be relatively safe, practical, and time-efficient ways to improve physical fitness and quality of life in previously untrained and clinical populations. However, the feasibility and effectiveness of their use by chronic lung disease patients, particularly those with bronchiectasis, is yet to be properly examined. The investigators therefore intend to recruit 10 bronchiectasis patients to explore the feasibility and effectiveness of minimal-equipment interval exercise interventions in this population. More specifically, the investigators would like to observe patients' acute physical and perceptual responses to four different step and walk-based protocols which have been established for other clinical populations. The investigators also wish to explore whether these protocols are engaged with, and enjoyed, during a six week unsupervised exercise intervention (in the home), as well as the effects of this six week unsupervised exercise period on physical fitness. This project will hopefully make a valuable contribution to the limited research to have examined the real-world application and impact of interval-type exercise interventions on exercise behaviour, health, and symptoms in bronchiectasis sufferers.
Detailed Description
Baseline testing (Visit 1) Having completed informed consent and screening, participants will be invited to complete a hospital-based baseline physiological testing session. The usual care of this participant group means that a clinical assessment of condition severity and associated spirometry measures (e.g. peak flow, forced vital capacity) will have already been completed which will be included in the study data. If this is not the case, then a member of the patient's usual care team (which may include members of the research team) will collect these baseline measures. Baseline physiological assessment will then be completed, including a self-paced six minute walk test (6MWT); an Isometric Quadriceps Strength Test (IQST); and an incremental, externally paced, symptom-limited Chester Step Test (CST ). Peak values for cardiorespiratory measures (i.e. heart rate, oxygen consumption and saturation, minute ventilation) will be established by way of clinically validated metabolic cart, oximeter and facemask applied during the incremental CST. Each of these tests will be delivered in the stated order across a 60 minute period, with each test followed by at least 5 minutes of rest to allow for adequate recovery and instruction.
Acute high-intensity interval exercise trials (Visits 2-5) Four subsequent hospital-based (supervised) trials will require participants to complete differing formats of step-based or walking-based HIIE, in a randomised order established by an online random sequence generator. Mean and peak values for cardiorespiratory responses (i.e. heart rate, oxygen consumption, minute ventilation) will be established by way of clinically validated metabolic cart and face-mask applied for the duration of each protocol. Whilst the same format of each HIIE session will prescribed to each participant, their completion of each work and rest period (and the duration of these) will be subject to symptom limitation (i.e. they will be permitted to shorten work and/or extend rest periods if symptoms dictate).
Post-HIIE questions will be verbally asked of participants at the end of each exercise session, including;
Did they enjoy this type of exercise? Would they like to try this exercise at home? Did they feel safe when completing this exercise? What will be the major barrier for them to not try this exercise at home?
In addition to their initial responses, participants will be invited to offer a brief explanation as appropriate. All responses will be recorded by dictaphone and subsequently transcribed by a member of the research team for later analysis.
Unsupervised 6 week high-intensity interval exercise intervention Having completed all acute high-intensity interval exercise trials, participants will then complete 6 weeks of home-based unsupervised exercise, initially incorporating their preferred format of stair and/or walking-based HIIE, three days per week. They will be encouraged to gradually progress exercise load (i.e. repetitions, work-to-rest ratio, and/or sessions per week) to a maximum of 6 x 60 seconds, five times per week (i.e. ~12 minutes total). Measures of physiological status, symptoms and well-being will be logged throughout (i.e. heart rate, dyspnea, respiratory quality of life, anxiety and depression).
Follow-up testing (Visit 6) Upon completion of home-based unsupervised exercise intervention, baseline physiological assessments will be repeated in the hospital setting. This will again include a self-paced MWT; an IQS test; and an incremental, externally paced, symptom-limited CST. Peak values for cardiorespiratory measures (i.e. heart rate, oxygen consumption, minute ventilation) will be established by way of clinically validated metabolic cart and facemask applied during the incremental CST. Each of these tests will be delivered in the stated order across a 60 minute period, with each test followed by at least 15 minutes of rest to allow for adequate recovery and instruction.
Following a similar approach to pre-intervention testing, post-intervention questions will be verbally asked of participants at the end of the follow up testing session, including; Did they enjoy this exercise intervention? Would they like to continue these types of exercise at home? Did they feel safe when completing these exercises at home? What will be the major barrier for them to not continue these types of exercise at home? What changes would make continuing this type of exercise more appealing to them?
In addition to their initial responses, participants will be invited to offer a brief explanation as appropriate. All responses will be recorded by dictaphone and subsequently transcribed by a member of the research team for later analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a pragmatic feasibility study of a single case group. However, examination of acute responses to different step and walk-based interval exercise types will follow a randomised, counter-balanced (repeated-measures) design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity interval exercise
Arm Type
Experimental
Arm Description
Completion of four separate step and walk-based high intensity interval exercise sessions, followed by completion of six week unsupervised (at home) high intensity interval exercise intervention
Intervention Type
Other
Intervention Name(s)
Step and walk-based high intensity interval exercise
Intervention Description
Four hospital-based trials will include two step-based (3 x 20 sec with 120 sec rest, or 3 x 60 sec with 60 sec rest) and two walking-based (e.g. 3 x 60 sec with 60 sec rest or 3 x 180 sec with 180 sec rest) interval exercise protocols, in a randomised and counterbalanced order.
Unsupervised (At home) exercise intervention will incorporate patients' preferred stair and/or walking-based interval exercise (from those completed during hospital trials). Initially patients will complete their chosen protocol three days per week, and then gradually progress exercise load (i.e. reps, work-to-rest ratio, and/or sessions per week) as appropriate, to a maximum of 6 x 60 sec stepping / 5 x 180 sec walking, five times per week (i.e. maximum of ~30 min daily or ~150 min weekly).
Primary Outcome Measure Information:
Title
Completion rate
Description
Completion rate (%) for each type of interval exercise protocol administered
Time Frame
Week 11 (i.e. visit 6)
Title
Emergent adverse events
Description
Number of adverse events (count) during high-intensity interval exercise protocols
Time Frame
Week 11 (i.e. visit 6)
Secondary Outcome Measure Information:
Title
Heart rate
Description
Mean and peak heart rate values (beats per minute)
Time Frame
Captured at Baseline and throughout each interval exercise bout during visits 2, 3, 4, 5 and 6 (i.e. weeks 1, 2, 3, 4, 5 and 11)
Title
Oxygen consumption
Description
Mean and peak oxygen consumption values (millilitres per kilogram per minute)
Time Frame
Captured at Baseline and throughout each interval exercise bout during visits 2, 3, 4, 5 and 6 (i.e. weeks 1, 2, 3, 4, 5 and 11)
Title
Minute ventilation
Description
Mean and peak minute ventilation values (litres per minute)
Time Frame
Captured at Baseline and throughout each interval exercise bout during visits 2, 3, 4, 5 and 6 (i.e. weeks 1, 2, 3, 4, 5 and 11)
Title
Respiratory frequency
Description
Mean and peak respiratory frequency values (breaths per minute)
Time Frame
Captured at Baseline and throughout each interval exercise bout during visits 2, 3, 4, 5 and 6 (i.e. weeks 1, 2, 3, 4, 5 and 11)
Title
Oxygen saturation
Description
Mean and peak oxygen saturation values (% SpO2)
Time Frame
Captured at Baseline and throughout each interval exercise bout during visits 2, 3, 4, 5 and 6 (i.e. weeks 1, 2, 3, 4, 5 and 11)
Title
Perceived fatigue during interval exercise
Description
Fatigue [Borg CR 0-10 Scale]
Time Frame
Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase
Title
Perceived breathlessness during interval exercise
Description
Perceived Breathlessness [Borg CR 0-10 Scale]
Time Frame
Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase
Title
Affect/Pleasure response to interval exercise
Description
Affect/Pleasure [Feeling Scale -5 to +5 Score]
Time Frame
Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase
Title
Six-Minute Walk Test Performance
Description
Six-Minute Walk Test (distance in meters)
Time Frame
Change from Baseline to visit 6 (i.e. weeks 1 to 11)
Title
Chester Step Test Performance
Description
Chester Step Test (final step rate in steps per minute)
Time Frame
Change from Baseline to visit 6 (i.e. weeks 1 to 11)
Title
Quadriceps Strength
Description
Isometric Quadriceps Strength Test (peak force [kg/N])
Time Frame
Change from Baseline to visit 6 (i.e. weeks 1 to 11)
Title
Patient perceptions of interval exercise protocols
Description
Interview questions
Time Frame
Captured during visits 2, 3, 4, 5 and 6 (i.e. weeks 2, 3, 4, 5 and 11)
Title
EuroQoL (EQ-5D-5L) questionnaire for health-related quality of life
Description
EuroQoL (EQ-5D-5L) questionnaire for health-related quality of life: 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels
Time Frame
Captured at Baseline and then weekly during intervention period (i.e. weeks 1, 6, 7, 8, 9, 10 and 11)
Title
Exacerbations and/or adverse events during interval exercise
Description
Event based, patient reported
Time Frame
Captured at Baseline and then weekly during intervention period (i.e. weeks 1, 6, 7, 8, 9, 10 and 11)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adults (i.e. >18 years)
Clinical diagnosis of non-cystic fibrosis bronchiectasis.
Registered/treated as an inpatient or outpatient with the United Lincolnshire NHS Trust
Capable of giving informed consent.
Deemed eligible for pulmonary rehabilitation (including exercise) by clinical specialist, specialist nurse, or respiratory physiotherapist.
Has not met national guidelines for exercise engagement during the preceding 3 months (i.e. completing at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity each week).
Exclusion Criteria:
Inability or unwillingness to sign informed consent;
Outside of stated age range (i.e. <18 years);
Pregnant;
Suffering from any major co-morbidity known to impair exercise tolerance (i.e. heart failure/disease, diabetes, neuromuscular and/or musculoskeletal disease or injury) or another factor considered as a contraindication to clinical exercise testing by clinical specialist respiratory physiotherapist;
Has met national guidelines for exercise engagement during the previous 3 months (i.e. completing at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity each week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny Taylor, PhD
Organizational Affiliation
University of Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lincoln County Hospital Physiotherapy Unity
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of Interval Exercise in Bronchiectasis
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