Preserved Ratio Impaired Spirometry (PRISM)
Conditions
Keywords
Preserved ratio impaired spirometry, PRISm, exercise with telehealth, walking exercise, smoking cessation
Brief summary
Preserved Ratio Impaired Spirometry (PRISm) describes individual with spirometry findings of forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted. While the spirometry findings of individuals with PRISm can be transited into obstructive pattern, remains at PRISm or become normal spirometry, limited evidence is on the role of exercise in the course of PRISm. This study aims to investigate the role of exercise, namely exercise with telehealth and walking exercise, together with smoking cessation advice, would alter the clinical course of PRISm.
Detailed description
The is an open-labelled prospective randomised control trial on individuals with spirometry findings of PRISm. Individuals who are smoker/ ex-smoker will be screened by spirometry. Eligible individuals who fulfill the inclusion and exclusion criteria will be recruited and randomised into exercise with telehealth group, exercise group and no exercise group into 1:1:1 ratio. The intervention period is 26 weeks and the follow up period is 52 weeks. In the intervention period, individuals will be instructed to exercise accordingly. In exercise with telehealth group, exercise with telehealth will be performed 2 times per week for 1 hour. In exercise group, individuals will be instructed to have exercise with each week's goal was the lowest of three numbers: (1) the average of the most recent 7 days of step counts + 600 steps, (2) the previous goal + 600 steps, or (3) 10,000 steps per day. In no exercise group, no exercise instruction will be given. Smoking cessation advice and clincial assessment including hospitalisation due to any respiratory or cardiovascular causes, modified Medical Research Council Dyspnea Scale, St George's Respiratory Questionnaire will be assessed in baseline, week 4, 8, 12, 26, 52. Spirometry by Spirodoc and 6 minute walk test will be assessed at baseline, week 12, 26 and 52.
Interventions
BEHAVIORALExercise with telehealth group
Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.
BEHAVIORALExercise group
Participants will exercise with walking. Smoking cessation advice will be given.
BEHAVIORALNo exercise group
No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.
Sponsors
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or above * Smoker/ ex-smoker * Spirometry shows PRISm, with FEV1/FVC \>= 0.7 and FEV1 \<80% predicted * Ambulatory to walk * Able to give informed consent
Exclusion criteria
* Age below 18 * Non-smoker * Spirometry does not show PRISm/ unable to perform spirometry * Requires assistance for walking * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk test distance | 1 year | The 6 minute walk test distance will be measured in the start of the study, at 3 months, 6 months and 12 months. The differences will be compared. |
Countries
China
Contacts
CONTACTKing Pui Florence Chan, MD
PRINCIPAL_INVESTIGATORKing Pui Florence Chan, MD
he University of Hong Kong, Queen Mary Hospital
Outcome results
None listed