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Feasibility of Interval Exercise in Bronchiectasis

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ClinicalTrials.gov Identifier: NCT03920124
Recruitment Status : Active, not recruiting
First Posted : April 18, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
United Lincolnshire Hospitals NHS Trust
Information provided by (Responsible Party):
University of Lincoln

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Step and walk-based high intensity interval exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Exploring the Feasibility and Effectiveness of Minimal-equipment High-intensity Interval Exercise (HIIE) Interventions in Bronchiectasis Patients
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : September 10, 2019
Estimated Study Completion Date : September 10, 2019

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Arm Intervention/treatment
Experimental: High intensity interval exercise
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
Other: Step and walk-based high intensity interval exercise

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 Measures :
  1. Completion rate [ Time Frame: Week 11 (i.e. visit 6) ]
    Completion rate (%) for each type of interval exercise protocol administered

  2. Emergent adverse events [ Time Frame: Week 11 (i.e. visit 6) ]
    Number of adverse events (count) during high-intensity interval exercise protocols


Secondary Outcome Measures :
  1. Heart rate [ 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) ]
    Mean and peak heart rate values (beats per minute)

  2. Oxygen consumption [ 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) ]
    Mean and peak oxygen consumption values (millilitres per kilogram per minute)

  3. Minute ventilation [ 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) ]
    Mean and peak minute ventilation values (litres per minute)

  4. Respiratory frequency [ 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) ]
    Mean and peak respiratory frequency values (breaths per minute)

  5. Oxygen saturation [ 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) ]
    Mean and peak oxygen saturation values (% SpO2)

  6. Perceived fatigue during interval exercise [ Time Frame: Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase ]
    Fatigue [Borg CR 0-10 Scale]

  7. Perceived breathlessness during interval exercise [ Time Frame: Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase ]
    Perceived Breathlessness [Borg CR 0-10 Scale]

  8. Affect/Pleasure response to interval exercise [ Time Frame: Captured during the final 3 min of interval exercise bouts and the first 3 mins of the post-exercise recovery phase ]
    Affect/Pleasure [Feeling Scale -5 to +5 Score]

  9. Six-Minute Walk Test Performance [ Time Frame: Change from Baseline to visit 6 (i.e. weeks 1 to 11) ]
    Six-Minute Walk Test (distance in meters)

  10. Chester Step Test Performance [ Time Frame: Change from Baseline to visit 6 (i.e. weeks 1 to 11) ]
    Chester Step Test (final step rate in steps per minute)

  11. Quadriceps Strength [ Time Frame: Change from Baseline to visit 6 (i.e. weeks 1 to 11) ]
    Isometric Quadriceps Strength Test (peak force [kg/N])

  12. Patient perceptions of interval exercise protocols [ Time Frame: Captured during visits 2, 3, 4, 5 and 6 (i.e. weeks 2, 3, 4, 5 and 11) ]
    Interview questions

  13. EuroQoL (EQ-5D-5L) questionnaire for health-related quality of life [ Time Frame: Captured at Baseline and then weekly during intervention period (i.e. weeks 1, 6, 7, 8, 9, 10 and 11) ]
    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

  14. Exacerbations and/or adverse events during interval exercise [ Time Frame: Captured at Baseline and then weekly during intervention period (i.e. weeks 1, 6, 7, 8, 9, 10 and 11) ]
    Event based, patient reported



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920124


Locations
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United Kingdom
Lincoln County Hospital Physiotherapy Unity
Lincoln, Lincolnshire, United Kingdom, LN2 5QY
Sponsors and Collaborators
University of Lincoln
United Lincolnshire Hospitals NHS Trust
Investigators
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Principal Investigator: Danny Taylor, PhD University of Lincoln

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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT03920124     History of Changes
Other Study ID Numbers: 180901
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases