NCT03120416

Brief Summary

The investigators aim to evaluate the feasibility of a resistance exercise training program among individuals with CKD and its impact on endothelial and vascular function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

April 4, 2017

Last Update Submit

April 15, 2019

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Measured by brachial artery flow-mediated dilation (FMD)

    3 months

Secondary Outcomes (8)

  • Vascular function

    3 months

  • Carotid artery stiffness

    3 months

  • Self-reported physical activity

    3 months

  • Objectively measured physical activity

    3 months

  • Systolic blood pressure

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Resistance exercise training program

EXPERIMENTAL

Eight exercises will be used to include large upper and lower body muscle groups. The baseline 1 repetition maximum (RM) will be used to set initial training loads. All exercise sessions will be performed under the supervision of an exercise physiologist. Vital signs and body weight will be recorded before each session. The workload during training will be adjusted to reflect 80% of the most recent 1 RM (approximately 8-12 RM set). In addition, patients' workloads will be progressively increased if the patients can lift the weight more than 12 repetitions. Participants will perform three sets of 8-12 repetitions on each machine per session.

Behavioral: Resistance exercise training

Control

NO INTERVENTION

Participants randomized to the control group will be offered an educational brochure regarding exercise published by the NKF.

Interventions

Resistance exercise trainingBEHAVIORAL

12-week resistance exercise training program, 2 times per week, 45 min per session. Eight exercises will be used to include large upper and lower body muscle groups (leg press, leg extension, leg curl, chest press, shoulder extension, biceps curl, abdominal crunch and back extension). The baseline one repetition maximum will be used to set initial training loads.

Resistance exercise training program

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CKD stage 3 or 4 (eGFR 15-60 ml/min/1.73m2)

You may not qualify if:

  • Currently institutionalized
  • Kidney transplant or dialysis
  • NY Heart Association class 3-4 heart failure
  • Dementia or cognitive impairment
  • Unstable angina or coronary revascularization within the last 3 months
  • Uncontrolled arrhythmia
  • Severe chronic lung disease
  • Orthopedic, neurologic or other condition that would preclude resistance exercise training
  • Pregnancy
  • Uncontrolled hypertension (systolic \> 160 mmHg and diastolic \>90 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ana C Ricardo, MD

    Assistant Professor of Medicine

    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
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 19, 2017

Study Start

January 25, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)