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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041678
Receipt No. R000045049
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
Date of disclosure of the study information 2020/09/04
Last modified on 2020/09/04

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Basic information
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
Condition chronic kidney disease
end-stage kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes bone mineral density
Key secondary outcomes physical function
physical activity
KDQOL
HADS

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Tohoku University Graduate School of Med
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本赤十字社医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 04 Day

Related information
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

Result
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

Progress
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
Other related information

Management information
Registered date
2020 Year 09 Month 04 Day
Last modified on
2020 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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