NCT04227587

Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia Disorder

Zero-time Exercise on Inactive Adults With Insomnia Disorder: A Randomized Controlled Trial and Mixed-method Process Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder

Detailed description

This randomized controlled trial (RCT) with a longitudinal mixed-method process evaluation aims to (1) determine the effectiveness of a ZTEx intervention program, which is a lifestyle-integrated physical activity program, on sleep and related outcomes in inactive adults with insomnia disorder; (2) identify the facilitators and barriers of ZTEx adherence, (3) explore the possible mechanisms of impact on ZTEx adherence and the same abovementioned outcomes. This RCT consists of two phases. In the first phase (baseline to week 8), 136 subjects will be randomly allocated to the ZTEx intervention or the sleep hygiene education (SHE) comparison group. They will receive two 2-hour ZTEx training or SHE lessons and practice ZTEx or follow the sleep hygiene instruction for 24 weeks. After assessment at week 8, for the second phase of the study (weeks 9-24), which is a proof-of-concept pilot nested in the RCT, subjects in the ZTEx group will be randomly divided into either an ZTEx with WhatsApp reminder (ZTEx+R) subgroup or an ZTEx without WhatsApp reminder (ZTEx alone) subgroup to evaluate the effects of WhatsApp reminders on exercise adherence and the same outcomes. Mixed methods process evaluation will be conducted. Post-training and post-follow-up qualitative focus group interviews will be conducted; facilitators, barriers, and mediators will be analyzed.

Conditions

• Insomnia, Primary

Interventions

Type	Name	Description
OTHER	Zero Time Exercise	Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
OTHER	Sleep hygiene education	We offer a 2-session education course to teach the subjects about sleep hygiene practice.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-04-30
• Completion: 2022-06-30
• First posted: 2020-01-13
• Last updated: 2023-06-12

Locations

1 site across 1 country: Hong Kong