UMIN-CTR Clinical Trial

Public title

Home-based exercise elicits favorable improvements in bone mineral density, physical function, and physical activity in peritoneal dialysis patients: a randomized pilot study

Acronym

Home-based exercise and bone mineral density in peritoneal dialysis patients: a randomized pilot study

Scientific Title

Home-based exercise elicits favorable improvements in bone mineral density, physical function, and physical activity in peritoneal dialysis patients: a randomized pilot study

Scientific Title:Acronym

Home-based exercise and bone mineral density in peritoneal dialysis patients: a randomized pilot study

Region

Japan

Condition

chronic kidney disease
end-stage kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

to examine the effects of a 6-month home-based exercise program on the BMD of PD patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

bone mineral density

Key secondary outcomes

physical function
physical activity
KDQOL
HADS

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

The intervention group performed a home-based exercise for 6 months. Based on the guideline, home-based exercises were walking,resistance exercises, and stretching. We requested participants to walk for 20-30 min at 3-5 times per week and to increase to 500-1000 steps depending on their ability every month. Resistance exercises for the upper body were performed using Thera-Band, including shoulder press, biceps curl, shoulder bench press in standing, or sitting. Lower body exercises include squat uncle calf-raise, hip abduction, and unipedal standing. Those exercises were started initially as one set of 10-15 repetitions and gradually increased up to the required number of sets using intensity-changing Thera-Band. The intensity of aerobic and resistance exercises was a Borg scale score of 11-13. Stretching exercises were targeted at a large muscle group. During the exercise intervention, we advised the participants to be careful not to pull the peritoneal catheter.
During their regular monthly hospital visit, patients performed home exercises under the supervision of a nurse to ensure compliance with the method, and lower aerobic exercise was performed using ergometer cycling. To adhere to the home-based exercise regimen, participants recorded the number of steps per day, repetition of resistance exercises, and frequency of exercise on a logbook with calendar-like pages. The patients brought this logbook during hospital visits for assessment.
We gave feedback and encouragement to the patients to continue exercising at home. In addition, we sent mails and called patients by phone to monitor them if they performed the home-based exercise fortnightly.

Interventions/Control_2

The usual care group was assigned a program that focused on well-being. These patients received instructions in stretching of the upper and lower body (low-frequency, low-intensity) for 6 months and were asked to live their life as usual.

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

37

years-old

<=

Age-upper limit

86

years-old

>

Gender

Male and Female

Key inclusion criteria

obtained patient's consent

Key exclusion criteria

(1) patients who had unstable hypertension
(2) patients who had recent myocardial infarction or unstable angina
(3) congestive heart failure (grade >II according to New York Heart Association Functional Classification)
(4) patients who had arthritic or orthopedic problems limiting exercise and walking with assistance
(5) patients who had cognitive disorder (mini-mental state examination score <24) .

Target sample size

56

Name of lead principal investigator

1st name	Watanabe
Middle name
Last name	Kumi

Organization

Japanese Red Cross Medical Center, Tokyo, Japan

Division name

Department of Nephrology

Zip code

150-8935

Address

4-1-22, hiroo, shibuya-ku, toukyo, , Japan

TEL

03-3400-1311

Email

kumi-k2@nifty.com

Name of contact person

1st name	Watanabe
Middle name
Last name	Kumi

Organization

Tohoku University Graduate School of Med

Division name

Department of Internal Medicine and Rehabilitation Science

Zip code

980-8574

Address

1-1, Seiryo-machi, Aoba-ku, Sendai City, Miyagi, Japan

TEL

022-717-7553

Homepage URL

Email

kumi-k2@nifty.com

Institute

Tohoku University Graduate School of Med

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

Tohoku University Graduate School of Med

Address

1-1, Seiryo-machi, Aoba-ku, Sendai City, Miyagi, Japan

Tel

022-717-7553

Email

kumi-k2@nifty.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本赤十字社医療センター（東京都）

Date of disclosure of the study information

2020

Year

09

Month

04

Day

URL releasing protocol

https://tohoku.repo.nii.ac.jp/index.php?action=pages_view_main&active_action=repository_view_main_it

Publication of results

Unpublished

URL related to results and publications

https://tohoku.repo.nii.ac.jp/index.php?action=pages_view_main&active_action=repository_view_main_it

Number of participants that the trial has enrolled

71

Results

There was no significant within-group change in BMD of the lumbar spine, femoral neck, and hip after 6 months of the exercise program. The intervention group had a significantly improved 30-s chair-stand test and 6-minute walk test and physical activity

Results date posted

2020

Year

09

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Outpatients undergoing PD from the Japanese Red Cross Hospital (Tokyo, Japan) from October 2017 to December 2017 were recruited.

Participant flow

71 patients were randomized into the intervention and usual care groups. Two patients from the intervention group and four patients from the usual care group did not receive the allocated intervention. Thus, a total of 65 patients were enrolled; however, only 53 (82%) patients completed the study

Adverse events

No adverse events directly related to the exercise training during the 6-month study period were reported. From the medical record, fracture (three patients) and peritonitis (three patients) were not attributed to the intervention exercise

Outcome measures

Based on dual X-ray absorptiometry, the primary outcomes were BMD data of the lumbar spine and proximal femoral neck. Secondary outcomes included physical functions, physical activity,QOL and HADS. The pre-and post-intervention values were compared.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

30

Day

Date of IRB

2017

Year

07

Month

30

Day

Anticipated trial start date

2018

Year

01

Month

01

Day

Last follow-up date

2018

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

09

Month

04

Day

Last modified on

2020

Year

09

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045049