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NCT03440320 · ClinicalTrials.gov registry record · NA
Online Education and Gentle Exercise Intervention
A NA study, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT03440320: Completed NA study, sponsored by Colorado State University.
NCT03440320 is a NA study that has completed, run by Colorado State University. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03440320, a NA study, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise intervention for chronic pain. In parallel, the researchers will develop a control group that includes exercise and health and wellness education. The expected outcomes include Education and Gentle Exercise intervention workbooks for participants and training and teaching manuals for interventionists leading the Education and Gentle Exercise intervention group and control group. Aim 2: Assess feasibility and acceptability of an online intervention, the Education and Gentle Exercise and research procedures including planned assessments. In this small RCT, the researchers will examine feasibility and acceptability of the 8-week Education and Gentle Exercise procedures and intervention compared to an exercise and health and wellness education control group. Participants will include 30 caregiving dyads randomly assigned to the two groups (15 dyads for Education and Gentle Exercise, and 15 dyads for control group; N = 30 dyads/60 participants). The primary hypothesis is that Education and Gentle Exercise will be feasible and acceptable to caregiving dyads, as measured by benchmarks for recruitment, screening, attendance, and completion of assessments and intervention. Surveys will be administered and focus groups will be conducted to understand participant satisfaction and experiences with Education and Gentle Exercise. After each intervention session, interventionists, caregivers, and care recipients will rate their satisfaction with the session content and activities.
Primary Outcome
Change from baseline in pain on the Brief Pain Inventory scale following the 8-week intervention. The measure scores range from 0 to 10 with higher scores indicating more severe pain and greater interference. Reported scores indicate the change in scores from baseline to 8-weeks (after the intervention), with a potential range from -10 to 10. Negative scores would indicate and improvement (decrease) in pain severity and interference, while positive scores indicate an increase in pain severity an
Interventions
- BEHAVIORAL MY-SKILLS - online
- BEHAVIORAL MY-Plan control - online
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2021-05-12 |
| Phase | NA |
What the finished NCT03440320 record still lists
NCT03440320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which MY-SKILLS - online is the first listed.
NCT03440320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03440320 about?
NCT03440320 is a clinical study titled "Online Education and Gentle Exercise Intervention". Aim 1: Develop and manualize the Education and Gentle Exercise intervention. Using focus groups, clinical reasoning, literature, and findings from previously tested interventions of yoga and self-management, the researchers will develop, refine, and standardize the Education and Gentle Exercise inte...
What is the current status of trial NCT03440320?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2018-03-29. Estimated completion is 2021-05-12.
What interventions are being tested in trial NCT03440320?
The interventions under investigation include: MY-SKILLS - online (BEHAVIORAL), MY-Plan control - online (BEHAVIORAL).
Who is sponsoring clinical trial NCT03440320?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03440320's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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