Feasibility of Interval Exercise in Bronchiectasis

NCT03920124 | Completed DMC

• 1 other identifier: 180901
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (2)

• Completion rate

  Completion rate (%) for each type of interval exercise protocol administered

  Week 11 (i.e. visit 6)

• Emergent adverse events

  Number of adverse events (count) during high-intensity interval exercise protocols

  Week 11 (i.e. visit 6)

Secondary Outcomes (14)

• Heart rate

  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)

• Oxygen consumption

  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)

• Minute ventilation

  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)

• Respiratory frequency

  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)

• Oxygen saturation

  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)

Study Arms (1)

High intensity interval exercise

EXPERIMENTAL

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

Interventions

Step and walk-based high intensity interval exercise OTHER

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).

High intensity interval exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lincoln: lead
• United Lincolnshire Hospitals NHS Trust: collaborator

Study Sites (1)

Lincoln County Hospital Physiotherapy Unity

Lincoln, Lincolnshire, LN2 5QY, United Kingdom

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Danny Taylor, PhD

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: April 18, 2019
• Study Start: June 5, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)