Trial no.:	PACTR202209591144366	Date of Approval:	15/09/2022
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Effect of minimally invasive cardiac surgery compared with conventional surgery on post-operative physical activity and rehabilitation in patients with valvular heart disease

Official scientific title

Effect of minimally invasive cardiac surgery versus conventional surgery on post-operative physical activity and rehabilitation in valvular heart disease patients

Brief summary describing the background and objectives of the trial

the concept and practice of minimally invasive cardiac surgery (MICS ) have gradually grown in popularity. The growth has been driven by multiple factors. Minimally invasive cardiac surgery (MICS) is less invasive, the quicker postoperative recovery, a higher margin of benefit/cost ratio, and speedy recovery to normalcy. patients who underwent MICS maintain higher levels of physical activity than those who underwent conventional median sternotomy. It is well known that physical activity reduces the risk of cardiovascular disease and the mortality rate, Low levels of physical activity in older patients during hospitalization have been linked to loss of functional ability. The goal is to compare and evaluate physical activity using MICS and conventional approaches.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

cardiac surgery and rehabilitation ,Surgery

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Physical activity and nutrition

Anticipated trial start date

01/04/2020

Actual trial start date

02/05/2020

Anticipated date of last follow up

09/06/2021

Actual Last follow-up date

04/05/2022

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

50

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using a randomization table created by a computer software program	Numbered containers	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	rehabilitation program	everyday session each session for 30 min	10 dayes	waking , range of motion, aerobic exercise	25	Active-Treatment of Control Group
Experimental Group	rehabilitation prog	everyday session each session 30 min	10 dayes	walking , range of motion , aerobic exercise	25

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
60 consecutive patients who underwent elective surgery for mitral valve disease were prospectively enrolled in the study	patients will be excluded from this study if they are : 1- independent in activities of daily living (ADL) before surgery, 2- their physical activity is restricted before surgery, 3- or they record 1,000 or fewer steps before surgery	Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	22 Year(s)	70 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

13/04/2022

Research Ethics Committee at the faculty of medicine Ain shams university

Ethics Committee Address
Street address	City	Postal code	Country
56 Ramsis St., Abbasseya, Cairo	cairo	11511	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	All subjects were subjected to (i) measurement of The amount of physical activity before and after surgery, (ii) Assessment after the Postoperative rehabilitation program using the Visual Analog Scale (VAS) for the pain, the day of the Standing at the bedside and the day at which the subject could do 100 m independent walking (iii) 6MWT before and after surgery	from the day after admission, until the day before discharge
Secondary Outcome	All subjects were subjected to (i) measurement of The amount of physical activity before and after surgery , (ii) Assessment after the Postoperative rehabilitation program using Visual Analoge Scale (VAS) for the pain , the day of the Standing at the bed side and the day at which the subject had the ability to do 100 m independent walking (iii) 6MWT before and after surgery	the day before discharge

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Department of Cardiothoracic Surgery Ain shams university	56 Ramsis St., Abbasseya, Cairo	Cairo	11511	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Hossam salaheldin Abdelmohsen Labib	56 Ramsis St., Abbasseya, Cairo	Cairo	11511	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Ain shams university	56 Ramsis St., Abbasseya, Cairo	cairo	11511	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	hossam labib	hossam_salah@med.asu.edu.eg	+201002058687	56 Ramsis St., Abbasseya, Cairo
City	Postal code	Country	Position/Affiliation
cairo	11511	Egypt	Lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Moustafa ELBarabary	cardioknight@med.asu.edu.eg	+201111795296	56 Ramsis St., Abbasseya
City	Postal code	Country	Position/Affiliation
cairo	11511	Egypt	lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	hossam labib	hossam_salah@med.asu.edu.eg	+201002058687	56 Ramsis St., Abbasseya
City	Postal code	Country	Position/Affiliation
cairo	11511	Egypt	lecterur

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	study, conducted on 50 consecutive patients who underwent elective surgery for valvular disease were prospectively enrolled. The subjects had been randomly divided to two group based on the surgical procedure, the MICS group and the conventional group. Age, height, weight and the preoperative cardiac functions discrepancies across groups haven't been significant (table 1).) Postoperative rehabilitation data is shown in (Table 2). Postoperative progress was quicker in the MICS group than in the conventional group (postoperative day of standing at the bedside was 1.84 ± 0.37 vs. 2.28 ± 0.68 days, p<0.01) and 100-m independent walking postoperative was 3.24 ± 0.72 vs 5.08 ± 0.70 days, p<0.01). Also there was significant improvement as regard post-operative pain score (VAS) in MICS group, p<0.01). The amount of physical activity in both groups before and after surgery is shown in (Table 3). There was no significant difference in the number of preoperative daily steps between the two groups. The number of daily steps showed a significant increase in the MICS group (preoperative 2,740.4 ± 1,330.2 vs. postoperative 3,536.8 ± 1,885.3, The difference in the amount of physical activity in both group is shown in table 3. This is meaning that the rate of change in daily steps, pre- and postoperatively, was significantly higher in the MICS group than the conventional group (793.28 ± 543.29 vs. 181.96 ± 205., p<0.01). The result of 6MWT in both groups before and after surgery is shown in (Table 4). There was no significant difference in the test preoperative between the two groups. The test showed a significant increase in the MICS group (preoperative 2,740.4 ± 1,330.2 vs. postoperative 3,536.8 ± 1,885.3, p<0.01). Table (1) : Demographic data and the patient characteristics and surgical data Conventional group MICS group P-value Sig. No. = 25 No. = 25 Age Mean ± SD 49.08 ± 12.91 48.68 ± 12.77 0.913 NS Range 26 – 68 22 – 70 Gender Female 16 (64.0%) 12 (48.0%) 0.254 NS Male 9 (36.0%) 13 (52.0%) BMI Mean ± SD 26.41 ± 4.62 26.50 ± 4.31 0.947 NS Range 19.3 – 36 18.3 – 34 DM No 21 (84.0%) 20 (80.0%) 0.713 NS Yes 4 (16.0%) 5 (20.0%) HTN No 13 (52.0%) 14 (56.0%) 0.777 NS Yes 12 (48.0%) 11 (44.0%) Liver disease No 22 (88.0%) 22 (88.0%) 1.000 NS Yes 3 (12.0%) 3 (12.0%) LVEF Mean ± SD 59.08 ± 9.18 60.40 ± 8.86 0.607 NS Range 39 – 71 38 – 72 LVDd (mm) Mean ± SD 51.56 ± 9.01 52.88 ± 7.37 0.573 NS Range 33 – 70 39 – 66 P-value >0.05: Non significant (NS); P-value <0.05: Significant (S); P-value< 0.01: highly significant (HS) :Chi-square test; •: Independent t-test Table 2 : Postoperative rehabilitation data and VAS score Conventional group MICS group P-value Sig. No. = 25 No. = 25 Standing at the bed side (Postoperative day) Mean ± SD 2.28 ± 0.68 1.84 ± 0.37 0.007 HS Range 1 – 3 1 – 2 100 m independent walking (Postoperative day ) Mean ± SD 5.08 ± 0.70 3.24 ± 0.72 <0.001 HS Range 4 – 6 2 – 5 VAS score Median (IQR) 4 (5 - 6) 4 (3 - 4) <0.001 HS Range 4 – 8 3 – 6 P-value > 0.05: Non significant; P-value < 0.05: Significant; P-value < 0.01: Highly significant •: Independent t-test; ≠: Mann-Whitney test Table 3: The amount of physical activity before and after surgery measured by triaxial accelerometer (steps/ day) The amount of physical activity before surgery (steps/day) Conventional group MICS group P-value Sig. No. = 25 No. = 25 Pre-operative Mean ± SD 2534.68 ± 584.86 2418.60 ± 418.41 0.424 NS Range 1348 – 3764 1853 – 3245 Post-operative Mean ± SD 2716.64 ± 584.53 3211.88 ± 594.94 0.005 HS Range 1949 – 3876 1986 – 4001 Difference Mean ± SD 181.96 ± 205.00 793.28 ± 543.29 <0.001 HS Range 1 – 632 88 – 1894 Paired t-test 4.438 7.301 P-value <0.001 (HS) <0.001 (HS) P-value > 0.05: Non significant; P-value < 0.05: Significant; P-value < 0.01: Highly significant : Chi-square test Table (4): The result of 6MWT in both groups before and after surgery 6MWT Conventional group MICS group P-value Sig. No. = 25 No. = 25 Pre operative Mean ± SD 340.88 ± 69.53 346.72 ± 55.76 0.745 NS Range 209 – 493 289 – 488 Post operative Mean ± SD 410.56 ± 86.61 506.56 ± 86.92 <0.001 HS Range 291 – 596 339 – 632 Difference Mean ± SD 69.68 ± 56.11 159.84 ± 77.35 <0.001 HS Range 6 – 197 6 – 312 Paired t-test 6.209 10.333 P-value <0.001 (HS) <0.001 (HS) P-value > 0.05: Non significant; P-value < 0.05: Significant; P-value < 0.01: Highly significant *: Chi-square test	Informed Consent Form,Statistical Analysis Plan,Study Protocol	2 weeks	open key access
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	Yes		11/09/2022
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:
Result - 13/09/2022	Result - 13/09/2022
Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry