NCT03353844

Brief Summary

Low physical activity is associated with in hemodialysis and hemodiafiltration (HDF) patients. Previous studies showed the benefits of intradialytic exercise for improvement of physical fitness and hemodialysis adequacy. However, the effect of intradialytic exercise on physical activity has not been explored. This current open-labelled randomized controlled trial is conducted in HDF patients to determine the effect of intradialytic exercise program for 6 months on daily physical activity measured by tri-axial accelerometer (wearable device).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 9, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

November 8, 2017

Last Update Submit

July 24, 2018

Conditions

End Stage Renal DiseaseHemodialysisSedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

  • Change of daily physical activity at 6 months

    Every participant will be monitored their daily physical activity by wearable tri-axial accelerometer (Fitbit) before and at 6 months to observe changes in daily physical activity.

    at 0 and 6 months

Secondary Outcomes (3)

  • Dialysis adequacy as measured by kt/V

    at 6 months

  • Aerobic exercise capacity as measured by VO2 max

    at 6 months

  • Body composition (lean and fat body mass)

    at 6 months

Study Arms (2)

Intradialytic exercise group

EXPERIMENTAL

These patients will get intradialytic exercise every sessions of hemodiafiltration

Behavioral: Intradialytic exercise

Standard dialysis group

NO INTERVENTION

regular and standard of care in every hemodiafiltration sessions (as usual) without intradialytic exercise.

Interventions

Intradialytic exerciseBEHAVIORAL

intradialytic exercise which start and finish in first hour of hemodiafiltration session

Intradialytic exercise group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dialysis vintage more than 3 months
  • Sedentary or light physical activity

You may not qualify if:

  • recent myocardial infarction (\<12 months)
  • recent ischemic stroke (\<12months)
  • uncontrolled comorbidities (diabetes/hypertension/heart failure/heart disease/respiratory disease)
  • Life expectancy \< 12 months
  • active musculoskeletal problem e.g.) rheumatoid arthritis, spondyloarthropathy, osteoarthritis, fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location

Related Publications (1)

  • Assawasaksakul N, Sirichana W, Joosri W, Kulaputana O, Eksakulkla S, Ketanun C, Kittiskulnam P, Chantadisai M, Takkavatakarn K, Susantitaphong P, Praditpornsilpa K, Eiam-Ong S, Tiranathanagul K. Effects of intradialytic cycling exercise on daily physical activity, physical fitness, body composition, and clinical parameters in high-volume online hemodiafiltration patients: a pilot randomized-controlled trial. Int Urol Nephrol. 2021 Feb;53(2):359-371. doi: 10.1007/s11255-020-02677-7. Epub 2020 Oct 31.

    PMID: 33128722DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicSedentary Behavior

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 SymptomsBehavior

Study Officials

  • Khajohn Tiranathanagul, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

  • Nawaporn Assawasaksakul, MD

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 27, 2017

Study Start

November 9, 2017

Primary Completion

June 30, 2018

Study Completion

July 24, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

TH(1)