NCT03630432

Brief Summary

Aim to evaluate the impact of a pulmonary rehabilitation (rehab) programme tailored and delivered to overweight and obese patients with difficult asthma on:

  1. 1.Asthma related quality of life (primary outcome) and asthma control (secondary outcome)
  2. 2.Treatment burden and healthcare usage (secondary outcomes)
  3. 3.Physical activity level, exercise tolerance, lung function and inflammation (secondary outcome)
  4. 4.Anxiety and depression (secondary outcome)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2017

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

May 26, 2017

Last Update Submit

August 9, 2018

Conditions

Asthma

Keywords

SevereDifficultOverweight and obese

Outcome Measures

Primary Outcomes (1)

  • AQLQ- Asthma quality of life questionnaire

    change from week 0 to week 8 for pulmonary rehab vs usual care control group. AQLQ consists of 32 questions related to quality of life scored out of 7, and then averaged. Total score is out of 7 with 1 being the worst and 7 the best. There is also a score between 1 and 7 for 4 subscales which cover areas of symptoms, activity limitation, emotional function and environmental stimuli. These subscales are also averaged over a number of questions with 1 being worst and 7 best.

    8 weeks

Secondary Outcomes (14)

  • AQLQ- asthma quality of life questionnaire

    8 weeks

  • ACQ6- asthma control questionnaire 6

    8 weeks

  • ACQ6- asthma control questionnaire 6

    8 weeks

  • ACQ6- asthma control questionnaire 6

    48 (or 56) weeks depending on group

  • AQLQ

    48 (or 56) weeks depending on group

  • +9 more secondary outcomes

Study Arms (2)

Group A

ACTIVE COMPARATOR

Immediate 8 week course of pulmonary rehabilitation

Behavioral: Pulmonary rehabilitation

Group B

PLACEBO COMPARATOR

Initial 8 weeks of usual care

Other: Usual Care

Interventions

Pulmonary rehabilitationBEHAVIORAL

The pulmonary rehabilitation course will be provided on a rolling basis and for each individual will be of 8 weeks duration including once weekly, 1.5 hour hospital sessions and encouragement to perform twice weekly home exercise sessions. Hospital sessions will include 1 hour of supervised exercise and 30 minutes education. Exercise Component: This will include a combination of aerobic, resistance and flexibility training. Educational Component will cover many topics including what is asthma, treatments and inhaler technique, self-management, importance of exercise and health promotion. On completion of the formal pulmonary rehabilitation course, participants will be encouraged to continue regular exercise sessions by accessing community based "Vitality Classes".

Group A
Usual CareOTHER

Usual Care

Group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-80 year (smokers, ex-smokers and non-smokers)
  • Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015\[4\] with characteristic symptoms and at least one of the following:
  • Airflow limitation - FEV1/FVC \< 70% (at any time in the past) and 12% and 200ml increase in FEV1 in the preceding 5 years either:
  • i. After inhaled/nebulised bronchodilator or 4+ weeks of anti- inflammatory treatment ii. Between visits
  • Positive bronchial challenge in the preceding 5 years:
  • I. Histamine or methacholine provocation concentration causing a 20% drop in FEV1 (PC20) \<8mg/ml ii. Provoking dose of mannitol required to cause a drop in FEV1 of 15% (PD15) mannitol \<635mg
  • Difficult asthma defined as per Scottish Intercollegiate Guidelines Network(SIGN)/British Thoracic Society(BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:
  • ACQ6\>1.5
  • ≥2 systemic corticosteroid boosts in previous year
  • ≥1 hospitalization in previous year
  • BMI≥25 kg/m2
  • MRC dyspnoea scale ≥3/5

You may not qualify if:

  • ICU admission +/- mechanical ventilation in the previous year for asthma exacerbation
  • Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
  • Significant respiratory or other co-morbidity likely to influence the conduct of the study
  • Pregnancy and breast feeding
  • Severe and/or unstable cardiac disease
  • Impaired mobility that impacts on ability to participate in physical training
  • Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or Airsonett device; eligible if on treatment for \>6months or discontinued \>6 months ago.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

RECRUITING

Related Publications (1)

  • Ricketts HC, Sharma V, Steffensen F, Goodfellow A, Mackay E, MacDonald G, Buchan DS, Chaudhuri R, Cowan DC. A pragmatic randomised controlled trial of tailored pulmonary rehabilitation in participants with difficult-to-control asthma and elevated body mass index. BMC Pulm Med. 2022 Sep 24;22(1):363. doi: 10.1186/s12890-022-02152-2.

    PMID: 36153525DERIVED

MeSH Terms

Conditions

AsthmaLymphoma, FollicularOverweightObesity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Douglas C Cowan

CONTACT

01412115451douglas.cowan@ggc.scot.nhs.uk

Clare Ricketts

CONTACT

clare.ricketts@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised, parallel, controlled study of 8 weeks pulmonary rehabilitation versus usual care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2017

First Posted

August 14, 2018

Study Start

May 11, 2017

Primary Completion

May 10, 2019

Study Completion

December 1, 2019

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)