NCT03621176

Brief Summary

A home-based exercise program will be implemented in three different groups of participants: advanced chronic kidney disease, end-stage renal disease in substitutive treatment hemodialysis or peritoneal dialysis. Participants will be evaluated before the program, after 3 months and after 6 months from the starting of the program. During the first 3 months the researcher will phone them weekly to reinforce the exercise habit, and during the last three months, there will be no reinforcement. Assessment will include strength, functional capacity, health-related quality of life and depressive symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

July 23, 2018

Last Update Submit

February 26, 2019

Conditions

Keywords

ExerciseHealth-related quality of lifePhysical functionHemodialysisPeritoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline sit to stand 10 test at 12 and 24 weeks

    Sit to stand to sit test 10, time to perform 10 repetitions

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

Secondary Outcomes (13)

  • Change from baseline Six-minute walking test at 12 and 24 weeks

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

  • Change from baseline STS-60 at 12 and 24 weeks

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

  • Change from baseline OLHR at 12 and 24 weeks

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

  • Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

  • Change from baseline SPPB at 12 and 24 weeks

    Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks

  • +8 more secondary outcomes

Study Arms (1)

Home-based exercise

EXPERIMENTAL

Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group

Other: Home-based exercise

Interventions

A booklet with detailed information will be provided, and the exercises will be previously reviewed with every patient by the researcher. Participants will be encouraged to perform at least 3 sessions per week and monitor their heart rate. They will be instructed that the exercises should be perceived as 'somewhat hard' from a rate of perceived exertion. Adaptations to increase the intensity of the exercises will be provided so that participants can progress in exercise intensity

Home-based exercise

Eligibility Criteria

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

You may qualify if:

  • At least 3 months in hemodialysis treatment
  • Clinically stable

You may not qualify if:

  • Recent cardiac events (less than 3 months)
  • Unable to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (2)

  • Esteve Simo V, Junque Jimenez A, Moreno Guzman F, Carneiro Oliveira J, Fulquet Nicolas M, Pou Potau M, Saurina Sole A, Duarte Gallego V, Tapia Gonzalez I, Ramirez de Arellano M. Benefits of a low intensity exercise programme during haemodialysis sessions in elderly patients. Nefrologia. 2015;35(4):385-94. doi: 10.1016/j.nefro.2015.03.006. Epub 2015 Jul 21. English, Spanish.

    PMID: 26306966BACKGROUND
  • Segura-Orti E, Martinez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.

    PMID: 21719637BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, ChronicMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vicent Esteve-Simó, PhD

    Hospital de Terrassa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will undertake the exercise intervention. We will compare effects of the intervention between different cohorts included (advanced chronic kidney disease, end-stage renal disease hemodialysis o peritoneal dialysis)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2018

First Posted

August 8, 2018

Study Start

August 1, 2018

Primary Completion

January 31, 2019

Study Completion

February 14, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations