Role of Exercise in PRISm

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Preserved Ratio Impaired Spirometry (PRISM)

Treatments: Behavioral: Exercise group; Behavioral: No exercise group; Behavioral: Exercise with telehealth group

Study type: Interventional

Funder types: Other

Identifiers

NCT07387432

UW 24-461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Umable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Exercise with telehealth group

Experimental group

Description:

Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given

Treatment:

Behavioral: Exercise with telehealth group

Exercise group

Active Comparator group

Description:

Participants will exercise with walking. Smoking cessation advice will be given

Treatment:

Behavioral: Exercise group

No exercise group

Active Comparator group

Description:

No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given

Treatment:

Behavioral: No exercise group