UMIN-CTR Clinical Trial

Public title

Impact of Information Provision regarding PICS using ICU Diaries and
Grip Strength Charts on Physical Function in Post-Cardiac Surgery Patients

Acronym

Impact of Information Provision regarding PICS using ICU Diaries and
Grip Strength Charts on Physical Function in Post-Cardiac Surgery Patients

Scientific Title

Impact of Information Provision regarding PICS using ICU Diaries and
Grip Strength Charts on Physical Function in Post-Cardiac Surgery Patients

Scientific Title:Acronym

Impact of Information Provision regarding PICS using ICU Diaries and
Grip Strength Charts on Physical Function in Post-Cardiac Surgery Patients

Region

Japan

Condition

Post-intensive care syndrome , Patients after cardiac surgery, Physical functional decline, Motivation for rehabilitation

Classification by specialty

Surgery in general	Intensive care medicine	Rehabilitation medicine
Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

A combined intervention will be implemented for cardiac surgery patients, comprising preoperative information provision regarding PICS alongside feedback during ICU stay using ICU diaries and grip strength progression charts. This exploratory study will investigate the feasibility of the intervention and its effects on postoperative physical function and rehabilitation motivation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Change in physical function (handgrip strength, Barthel Index, and 6-minute walk distance) from admission to discharge

Key secondary outcomes

1. Motivation for rehabilitation (PRPS, BREQ-3) 2. Physical function during ICU stay (FSS-ICU) 3. Patient's subjective evaluation of the intervention (questionnaire survey)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

A combined nursing intervention for cardiac surgery patients was implemented, consisting of 1) preoperative education on PICS using pamphlets, 2) the use of ICU diaries (recording clinical progress and patient comments) during the ICU stay, and 3) visual feedback provided by charting handgrip strength measurements during rehabilitation.

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

Age-lower limit

18

years-old

<

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients aged 18years or older.
Patients undergoing elective cardiac surgery.
Patients requiring the use of cardiopulmonary bypass during surgery.
Patients staying in the ICU for 48hours or more postoperatively.

Key exclusion criteria

Preoperative cognitive impairment (Level III or higher) or psychiatric symptoms hindering communication.

Preoperative motor dysfunction (unable to walk).

Preoperative LVEF < 40% or NYHA Class IV or higher.

Postoperative onset of cerebrovascular disorders (consciousness disorder or paralysis).

Inability to wean from mechanical circulatory support postoperatively.

Readmission to the ICU or death before discharge.

Target sample size

20

Name of lead principal investigator

1st name	megumi
Middle name
Last name	yamamori

Organization

Graduate School of Nursing, Nagoya City University

Division name

Advanced Nursing Science

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho Ward, Nagoya City, Aichi Prefecture

TEL

052-853-8864

Email

megmogmeg519@gmail.com

Name of contact person

1st name	megumi
Middle name
Last name	yamamori

Organization

JA Aichi Koseiren Kainan Hospital

Division name

Intensive Care Unit

Zip code

498-8502

Address

396 minamihonda maegusucho yatomi city, aichi prefecture

TEL

0567-65-2511

Homepage URL

Email

megmogmeg519@gmail.com

Institute

Nagoya City University

Institute

Department

Personal name

Organization

Nagoya City University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya City University Graduate School of Nursing

Address

1 Kawasumi, Mizuho-cho, Mizuho Ward, Nagoya City, Aichi Prefecture

Tel

052-853-8864

Email

megmogmeg519@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

JA愛知厚生連海南病院

Date of disclosure of the study information

2026

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

Results

Multimodal intervention (PICS education, ICU diary, grip strength visualization) was applied to 20 cardiac surgery patients. Grip strength change rate was significantly better in the intervention group vs. historical controls (n=21) (+2.94% vs. -6.04%, p=0.041). No significant decline in Barthel Index or 6-minute walk distance. PRPS at first ICU rehabilitation correlated positively with grip strength change (r=0.474, p=0.035). Questionnaire scores (n=19) were high for all components (median 4-5/5).

Results date posted

2026

Year

02

Month

28

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Intervention group (n=20): Mean age 69.15+/-9.22 years; 14 males (70%). BMI 24.41+/-3.19 kg/m2. Comorbidities included hypertension (n=14), diabetes mellitus (n=12), and dyslipidemia (n=9). NYHA classification: Class I in 14, Class II in 6. Mean preoperative LVEF was 55.46+/-9.77%. Surgical procedures: CABG (n=14), AVR (n=4), MVR (n=1), CABG + other (n=1). Mean operative time 363.45+/-62.44 min; CPB time 163.5+/-37.06 min; aortic cross-clamp time 110.95+/-26.16 min. Mean ventilation time 30.9+/-17.66 hours; SOFA score on ICU admission 5.5+/-2.25. ICU-acquired delirium occurred in 5 patients. Mean ICU stay 3.19+/-1.37 days; total hospitalization 23.35+/-7.68 days. All 20 patients were discharged home. Historical control group (n=21): Mean age 68.09+/-12.62 years; 16 males (76%). Mean ICU stay 2.85+/-0.72 days; total hospitalization 24.00+/-9.97 days. Delirium occurred in 9 patients. No significant differences between groups were observed in age, sex, delirium incidence, ICU stay, hospitalization length, CPB time, or aortic cross-clamp

Participant flow

Between June and October 2025, 25 patients undergoing elective cardiac surgery at a single institution were screened for eligibility. Five patients were excluded: 1 due to severe preoperative cognitive impairment precluding conversation, 2 due to preoperative motor dysfunction, and 2 who declined participation. Twenty patients were enrolled in the intervention group. All 20 completed the full study protocol and were followed through discharge; no dropouts or withdrawals occurred. All participants were discharged home. The patient-reported questionnaire was collected from 19 of 20 patients at discharge (1 patient was unable to complete it due to poor physical condition at the time of discharge). The historical control group (n=21) was identified retrospectively from medical records of patients who underwent elective cardiac surgery at the same institution between September 2024 and May 2025.

Adverse events

No adverse events related to the intervention (PICS education, ICU diary, or grip strength visualization) were observed throughout the study period. No falls, clinically significant vital sign deterioration, or musculoskeletal injuries occurred during rehabilitation sessions. ICU-acquired delirium was observed in 5 of 20 intervention-group patients (25%), which was considered an anticipated clinical event in the postoperative cardiac surgery context and was not attributed to the study intervention. No deaths or emergency reoperations occurred during the study period. All 20 participants were discharged home without serious adverse events.

Outcome measures

Primary outcomes: Changes in physical function between admission and discharge, assessed by grip strength (kg), Barthel Index (BI), and 6-minute walk test (6MWT). For grip strength, the primary analysis compared the change score and percentage change between the intervention group and a historical control group.
Secondary outcomes: (1) Longitudinal changes in rehabilitation motivation assessed by BREQ-3 (at 4 timepoints: admission, ICU discharge, 1 week post-ICU discharge, and hospital discharge) and PRPS (at 5 timepoints: admission, first ICU rehabilitation session, ICU discharge, 1 week post-ICU discharge, and hospital discharge); (2) Correlation between motivation scores (BREQ-3, PRPS) and physical function outcomes (grip strength, 6MWT change rates); (3) Patient-reported feedback on the intervention (an 11-item original questionnaire using a 5-point Likert scale assessing the perceived utility of the ICU diary, grip strength visualization, and PICS education, administered at hospital discharge).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2025

Year

03

Month

03

Day

Date of IRB

2025

Year

03

Month

03

Day

Anticipated trial start date

2025

Year

06

Month

01

Day

Last follow-up date

2025

Year

11

Month

30

Day

Date of closure to data entry

2025

Year

12

Month

01

Day

Date trial data considered complete

2025

Year

12

Month

10

Day

Date analysis concluded

2025

Year

12

Month

20

Day

Other related information

Registered date

2026

Year

02

Month

28

Day

Last modified on

2026

Year

02

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069503