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The RELAX Trial: Nonpharmaceutical Intervention for Nocturnal Muscle Cramps

NCT05457322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-09-11

No results posted yet for this study

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.

Conditions

  • Cramps
  • Muscle Cramp

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Elliot Tapper, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2023-08-14
Completion
2023-08-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457322 on ClinicalTrials.gov