Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00446

2 Trial Registration Date

2015-02-06

i Registration Status

Prospective

3 Secondary IDs

NTWC/CREC/1376/14

4 Source(s) of Funding

Physiotherapy department, Tuen Mun Hospital

5 Primary Sponsor

Tuen Mun Hospital, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Fan Kit Yi

ii Address

Physiotherapy department, Special Block, Tuen Mun Hospital

iii Phone

61721898

iv Email

fky882@ha.org.hk

v Affiliation

Tuen Mun Hospital

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Fan Kit Yi

ii Address

Physiotherapy department, Special Block, Tuen Mun Hospital

iii Phone

61721898

iv Email

fky882@ha.org.hk

v Affiliation

Tuen Mun Hospital

vi Country

9 Official Scientific Title of the Study

Exercise Prescription for Patients with Colorectal Cancer

10 Public Title

Exercise Prescription for Patients with Colorectal Cancer

i Public Title in Chinese 研究名稱

對腸癌病人的運動治療

11 Short Title (Optional)

Exercise Prescription for Patients with Colorectal Cancer

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-01-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Colorectal cancer

15 Intervention

i Types of intervention

Other

Please specify

exercise training

ii Description/ name of Intervention/article

Group exercise training for Patients with colorectal cancer after operation and chemotherapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

8weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Patients with colorectal cancer after operation and chemotherapy do not receive any physical training

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

-At least 1 months post-cancer treatment
-Medically suitable for exercise testing and for participation in physical activity
-Receive a score of 60 or more on the Karnofsky Performance Status Scale (KPS)
-Current physical activity levels that do not meet the recommended exercise program guidelines

ii Exclusion Criteria

-Significant comorbid conditions
-Seizure disorder, psychotic disorder, or severe cognitive impairment
-Current treatment with additional chemotherapy or radiation
Bone metastasis

iii Age Minimum

40

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-03-18

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

-Recent significant weight loss (10lbs) in past 3 month
-Fatigue level with numeric rating scale with 0-10
-Resting BP/P
-Handgrip
-Quadriceps strength
-30 second sit to stand test
-Functional reach
-Personal Wellbeing Index

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-03-07

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-02-06