NCT05457322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2023

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

July 9, 2022

Last Update Submit

September 8, 2023

Conditions

CrampsMuscle Cramp

Keywords

Nighttime muscle crampsCirrhosisLiver diseaseQualify of lifeSleepNon-Pharmaceutical intervention

Outcome Measures

Primary Outcomes (1)

  • Change in cramp severity after 35-days as measured by the Visual Analog Scale for Cramps

    This is a one question scale from 0 to 10; 0 indicates no cramps and 10 indicates worst cramps imaginable.

    baseline, 35 days

Secondary Outcomes (2)

  • Patient global impression of change (PGIC)

    35 days

  • Change in sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI).

    baseline, 35 days

Study Arms (2)

Behavioral intervention one

EXPERIMENTAL
Behavioral: Behavioral intervention one

Behavioral intervention two

EXPERIMENTAL
Behavioral: Behavioral intervention two

Interventions

Behavioral intervention oneBEHAVIORAL

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 intervention one
Behavioral intervention twoBEHAVIORAL

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 intervention two

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants have painful muscle spasms, cramps, or charley horses at night in feet or legs.
  • Participants have muscle cramps that happen at least four times in the past month. And the muscle cramps bother them.
  • For Cirrhosis patients only: diagnosis of cirrhosis based upon:
  • liver biopsy, or
  • history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, or
  • of the following 4 criteria:
  • Ultrasound (US), computerized tomography (CT) or Magnetic resonance imaging (MRI) imaging findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
  • FibroScan liver stiffness score \>13 kilopascal (kPa)
  • Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
  • CT, MRI or esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

You may not qualify if:

  • Non-English speaking
  • Unable or unwilling to provide consent
  • Pregnancy via self-report
  • Disorientation at the time of enrollment
  • History of multiple sclerosis
  • History of cerebral palsy
  • History of stroke with paralysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

University of Miami Health System

Miami, Florida, 33125, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Muscle CrampFibrosisLiver Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesDigestive System Diseases

Study Officials

  • Elliot Tapper, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

July 9, 2022

First Posted

July 14, 2022

Study Start

August 30, 2022

Primary Completion

August 14, 2023

Study Completion

August 14, 2023

Last Updated

September 11, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(6)