NCT03055299

Brief Summary

The goal of the COMprehensive EXercise (COMEX) pilot study is to test feasibility, tolerability and adherence of this novel video-based intra-dialytic chair exercise program for hemodialysis patients over 3 months.

Trial Health

87
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
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

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

January 23, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

January 23, 2017

Last Update Submit

July 2, 2018

Conditions

ESRD

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Feasibility will be estimated by calculating the % of eligible participants who consent to participate in the study.

    3 months

  • Number of participants with exercise-related adverse events

    Tolerability will be measured by assessing exercise related side effects - this will be done by weekly patient interviews and review of medical records

    3 months

  • Adherence rate

    Adherence will be calculated as % of participants who complete the 3 month COMEX intervention. Also, adherence to exercise will be calculated as % of exercise sessions completed

    3 months

Secondary Outcomes (7)

  • Fatigue

    3 months

  • Sleep

    3 months

  • Depression

    3 months

  • Global health

    3 months

  • Health related quality of life

    3 months

  • +2 more secondary outcomes

Study Arms (1)

COMEX

EXPERIMENTAL

Patients receive comprehensive exercise intervention

Other: COMEX intervention

Interventions

COMEX interventionOTHER

Comprehensive Exercise

COMEX

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients:
  • Age ≥18 years to 85 years
  • Undergoing maintenance hemodialysis for \>3 months at one of the participating dialysis sites
  • Patients must be willing and able to sign the consent form.
  • For providers:
  • Eligible if they are a registered nurse, dialysis technician, dialysis social worker, dietitian, dialysis unit administrator or nephrologist involved in providing care for one of the patient participants in the study

You may not qualify if:

  • For all patients:
  • Uncontrolled BP (\>180/100 mm Hg)
  • Inadequately dialyzed (Kt/V\<1.2)
  • History of Intradialytic hypotension (SBP\<90mm Hg) or hypertension (SBP\>180mmHg) during/post dialysis within last 1 month
  • Contraindication to exercise eg unstable angina, uncompensated congestive heart failure
  • Refractory/untreated psychiatric disorders
  • History of poor adherence to HD treatment.
  • Scheduled for living donor kidney transplant, intention to change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 6 months.
  • Currently in acute or chronic care hospital
  • Life expectancy \< 6 months or intention to withdraw dialysis therapy within 6 months.
  • Current pregnancy, or actively planning to become pregnant in the next 6 months
  • Currently a prisoner
  • Current use of investigational drugs or participation in another non-observational clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
  • Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
  • Unable or unwilling to provide informed consent or sign IRB-approved consent form
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Jhamb M, Devaraj SM, Alemairi M, Lavenburg LM, Shiva S, Yabes JG, Forman DE, Hergenroeder AL. A Comprehensive Exercise (COMEX) Intervention to Optimize Exercise Participation for Improving Patient-Centered Outcomes and Physical Functioning in Patients Receiving Hemodialysis: Development and Pilot Testing. Kidney Med. 2023 Sep 12;5(11):100720. doi: 10.1016/j.xkme.2023.100720. eCollection 2023 Nov.

    PMID: 37928754DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 16, 2017

Study Start

February 20, 2017

Primary Completion

March 10, 2018

Study Completion

April 30, 2018

Last Updated

July 3, 2018

Record last verified: 2018-07

Locations

US(1)