UMIN-ICDS Clinical Trial

Public title

Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial

Acronym

Effects of Home-based Exercise in CKD Stage 4 patients

Scientific Title

Home-based Aerobic Exercise and Resistance Training in CKD Stage 4 Patients: A Randomized Controlled Trial

Scientific Title:Acronym

Effects of Home-based Exercise in CKD Stage 4 patients

Region

Japan

Condition

CKD stage 4 patients

Classification by specialty

Endocrinology and Metabolism	Nephrology	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We investigated effects of a home-based exercise program in CKD stage 4 patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Exercise capacity assessed by incremental shuttle walking test and quality of life, evaluated 6 months after assignment

Key secondary outcomes

Parameters including renal function, arterial stiffness, body composition, grip and quadriceps strength evaluated 6 months after assignment
Cross-sectional association between exercise capacity and other parameters including HRQOL

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Regarding aerobic exercise, patients in the exercise group are asked to perform unsupervised walking thrice weekly for 6 months. The target training zone was set at 40-60% of the peak heart rate, as determined in the baseline incremental shuttle walking test.
Resistance training was prescribed at 40-70% of one repetition maximum (RM). One RM is the maximum amount of weight an individual can lift or press only once, and the target training weight was almost the same as the weight an individual could lift or press 10 times. Patients were instructed to train a variety of upper and lower body muscle groups for 1 set of 10 repetitions twice weekly.

Interventions/Control_2

No specific intervention

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Patients with CKD stages 4 (estimated glomerular filtration rate,15-29 mL/min/1.73 m2)

Key exclusion criteria

The exclusion criteria were as follows: uncontrolled hypertension (blood pressure [BP] >180/110 mmHg), severe anemia (hemoglobin level <7 mg/dL), active and proliferative diabetic retinopathy, symptomatic coronary artery disease or cerebrovascular disease within 3 months before study recruitment, current heart failure (New York Heart Association classes III and IV), symptomatic and fatal arrhythmia, significant valvular heart disease, and difficulty walking without a walking aid owing to orthopedic problems, a history of cerebrovascular disease, or a history of peripheral artery disease.

Target sample size

60

Name of lead principal investigator

1st name	Shu
Middle name
Last name	Wakino

Organization

Department of internal medicine, Keio University, School of Medicine

Division name

Division of Endocrinology, Metabolism and Nephrology

Zip code

160-8582

Address

35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan

TEL

+81-3-3353-1211(67441)

Email

shuwakino@z8.keio.jp

Name of contact person

1st name	Kiyotaka
Middle name
Last name	Uchiyama

Organization

Department of internal medicine, Keio University, School of Medicine

Division name

Division of Endocrinology, Metabolism and Nephrology

Zip code

160-8582

Address

35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan

TEL

+81-3-3353-1211(67378)

Homepage URL

Email

kiyo.0817.piyo@keio.jp

Institute

Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine Keio University, School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee, Keio University, School of Medicine

Address

35-banchi, Shinano-machi ,Shinjuku-ku,Tokyo, Japan

Tel

+81-3-3353-1211(62014)

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

46

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

09

Month

02

Day

Date of IRB

2018

Year

11

Month

08

Day

Anticipated trial start date

2018

Year

11

Month

19

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

10

Day

Last modified on

2020

Year

11

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039744