UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034651
Receipt number R000039029
Scientific Title Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise
Date of disclosure of the study information 2018/11/01
Last modified on 2023/11/06 13:27:38

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Basic information

Public title

Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise

Acronym

Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer

Scientific Title

Resistance training intervention for hemodialysis patients undergoing long-term intradialytic ergometer exercise

Scientific Title:Acronym

Resistance training for hemodialysis patients undergoing long-term intradialytic ergometer

Region

Japan


Condition

Condition

Chronic kidney disease, hemodialysis

Classification by specialty

Nephrology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The resistance training intervention for 3months is performed for hemodialysis patients undergoing long-term intradialytic ergometer exercise in this study. The effect of combined use of aerobic exercise and resistance training on hemodialysis patients undergoing long-term ergometer exercise intervention is verified by comparing the evaluation of the physical function before and after combination with resistance training.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Gait function before 3-months, before starting and after 3-months of exercise intervention.

Key secondary outcomes

Muscle strength, balance ability, and body composition before 3-months, before starting and after 3-months of exercise intervention.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The subjects who are performing supine-position ergometer exercise during dialysis for more than 6 months add in low intensity resistance training before dialysis in this study. The resistance training covers the upper limb and lower limb muscles which can be easily performed by sitting position and standing position and should be voluntary training. The method of resistance exercise is shown graphic display, and at the time of introduction, practical instruction is given by a physical therapist (PT). In accordance with the cardiac rehabilitation guideline, we will teach the subjects to perform the exercise from 10 to 15 times as 1 set, and 2 to 3 sets in accordance with the individual's degree of fatigue. When exercise cannot be done, ask the reasons why it cannot be done, and re-instruct if there are problems concerning implementation.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

The hemodialysis patients who currently undergoing ergometer exercise during dialysis or currently do not exercise but want exercise. Currently, patients between 40 and 81 years old are carrying out.

Key exclusion criteria

The patients who have not been approved by doctor about performing the resistance training or who have systolic blood pressure above 200 mmHg before exercise.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Noguchi

Organization

Konjo University

Division name

Faculty of Medical Health

Zip code

924-8511

Address

1200,kasama-cho,hakusan City, Ishikawa ,Japan

TEL

076-276-4400

Email

noguchi@kinjo.ac.jp


Public contact

Name of contact person

1st name Miho
Middle name
Last name Tanaka

Organization

Mizuho hospital

Division name

Rehabilitation

Zip code

929-0346

Address

422-1,katabata,tsubata-cho,kahoku-gun, Ishikawa ,Japan

TEL

076-255-3008

Homepage URL


Email

mizuho@tiara.ocn.ne.jp


Sponsor or person

Institute

Mizuho hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Mizuho Hospital

Address

422-1,katabata,tsubata-cho,kahoku-gun, Ishikawa ,Japan

Tel

076-255-3008

Email

mizuho@tiara.ocn.ne.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1589/jpts.34.110

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1589/jpts.34.110

Number of participants that the trial has enrolled

23

Results

6MD results were significantly improved after the additional combined intervention compared to before the additional combined intervention (p<0.05).

As a result of multiple regression analysis, only the average distance traveled was employed 6MD related as the independent variable.

Results date posted

2023 Year 11 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 02 Month 23 Day

Baseline Characteristics

Participants were 23 outpatients (21 males and 2 females) receiving hemodialysis at the Mizuho Hospital Dialysis Center.
All participants maintained mobility and had the ability to commute to the hospital on their own.

Participant flow

Participants were selected from 132 outpatients receiving hemodialysis at the Mizuho Hospital Dialysis Center, 23 of whom were outpatients who volunteered to participate in the intervention study on dialysis and exercise.
This study had (A) period of only supine ergometer exercise during dialysis and (B) period of additional combined intervention of supine ergometer exercise during dialysis plus resistance exercise before dialysis. A period was longer than 3 months, and most of the participants had been performing supine ergometer exercise during dialysis for years prior to the A period and had a long exercise history. The B period was set at 12 weeks. We compared the changes in physical function data over time at three assessment times: before and after the A and B periods.
Five participants withdrew during the B period, and 18 participants (16 males and 2 females) completed this study. Three of the participants had a prolonged B period due to restrictions caused by coronavirus infection. However, since studies of patients undergoing hemodialysis often set up suspension periods and account for dropouts, we examined the effect of including the suspension period in this study in the intention-to-treat analysis.

Adverse events

No adverse events were observed in this study.

Outcome measures

Measurements of physical function included grip strength, knee-extension muscle strength, one-leg standing time, timed up-and-go test (TUG), and 6-min walk distance test (6MD).
We recorded the number of days the supine ergometer exercise was implemented during the A period, and that for both the resistance training and supine ergometer exercises during the B period. Additionally, the driving distance of the supine ergometer during the A and B periods was recorded each time, and the average driving distance and total driving distance during the A and B periods were calculated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 02 Day

Date of IRB

2018 Year 09 Month 27 Day

Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2020 Year 02 Month 18 Day

Date of closure to data entry

2021 Year 06 Month 02 Day

Date trial data considered complete

2021 Year 06 Month 21 Day

Date analysis concluded

2021 Year 09 Month 22 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 25 Day

Last modified on

2023 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039029


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name