NCT05457322

The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to learn about reducing the symptoms and severity of nighttime lower body muscle cramps in patients with and without cirrhosis. Eligible participants will have an initial 7-day practice phase, followed by 28 days of one of two behavioral interventions.

Detailed description

The interventions in this trial can be done at home. Openly discussing the intervention groups with all participants prior to randomization thus poses a high risk of tainting the study because subjects in the one group may start doing the other groups exercises after having heard about it during the consent process as a way to potentially reduce the symptoms and severity of painful muscle cramps. Therefore, this study will conceal information regarding the nature of the interventions. Only participants randomized to the true intervention group will be told during the study period what the behavioral intervention is. Additionally, the title of this trial upon registration is listed slightly differently than it is listed with the Institutional Review Board (IRB), to provide scientific integrity with the masking requirements. When the trial is completed, the title will be amended to match the IRB approved title. At the conclusion of the study, at the time of the final follow-up assessments, all participants will be debriefed on the use of the concealment of the study object in this study.

Conditions

• Cramps
• Muscle Cramp

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral intervention one	Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.
BEHAVIORAL	Behavioral intervention two	Participants will view or listen to audiovisual material and engage in a daily 10-minute exercise. Following the practice period participants will continue to do the true 28-day intervention period in which they were randomized to.

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2022-07-14
• Last updated: 2023-09-11

Locations

6 sites across 1 country: United States