NCT07014111

Brief Summary

Fight Fatigue is evaluating the feasibility and acceptability of a combined progressive muscle relaxation and walking intervention to reduce fatigue for adults with end-stage kidney disease receiving in-center hemodialysis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress39%
Sep 2025Jun 2027

First Submitted

Initial submission to the registry

May 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

May 23, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

Fatigue

Outcome Measures

Primary Outcomes (4)

  • Feasibility of recruitment

    Recruitment metrics (enrolled/invited)

    Baseline to week 12

  • Feasibility of retention

    Retention in the study from baseline to week 12

    Baseline to week 12

  • Acceptability

    Participant rating of acceptability (e.g., enjoyable, easy to understand) via Likert scale questions and open ended questions

    End of study (Week 12)

  • Adherence to the study protocol

    Adherence to the intervention measured with adherence to step counts, number/duration of accesses on the study-specific website, and adherence to study procedures as evaluated with number of text messages read/sent messages read.

    Baseline to week 12

Other Outcomes (1)

  • Fatigue

    Baseline to week 12

Study Arms (2)

Fight Fatigue

EXPERIMENTAL

Combined progressive muscle relaxation and walking (increasing step count) 12-week intervention that consists of education/training followed by text messages

Behavioral: Fight Fatigue

Attention Control

ACTIVE COMPARATOR

End-stage kidney disease education, followed by text messages (over 12 weeks)

Other: Attention Control

Interventions

Fight FatigueBEHAVIORAL

Combined progressive muscle relaxation and walking (increasing step count) 12-week intervention that consists of education/training followed by text messages.

Fight Fatigue

End-stage kidney disease education

Attention Control

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of ESKD diagnosis and receiving hemodialysis for at least 3 months
  • Can read and speak English
  • Fatigue measured via visual analogue scale, score ≥4 over the last week
  • Able to stand and walk one block
  • Has a cell phone that can receive text messages

You may not qualify if:

  • Patient's nephrologist refuses for them to participate
  • Unstable angina
  • Unstable pulmonary disease or pulmonary symptoms that preclude participation
  • Lower-extremity amputation without prosthetic (BKA, AKA) -Orthopedic or neurologic condition that would preclude walking or tensing/releasing of muscles-
  • Cognitive impairment that, in the judgement of the research team, precludes trial participation
  • Participation in the formative phase of the development of Fight Fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UI Health/University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mary Hannan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 10, 2025

Study Start

September 2, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-06

Locations