Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000163707
Ethics application status
Approved
Date submitted
13/09/2021
Date registered
31/01/2022
Date last updated
17/09/2023
Date data sharing statement initially provided
31/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Pilates exercise on functional capacity, cancer-related fatigue, depression, salivary cortisol and quality of life among colorectal cancer survivors in Klang Valley, Malaysia.
Scientific title
Effects of Pilates exercise on functional capacity, cancer-related fatigue, depression, salivary cortisol and quality of life among colorectal cancer survivors in Klang Valley, Malaysia.
Secondary ID [1] 305276 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer survivors 323575 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321122 321122 0 0
Other physical medicine / rehabilitation
Cancer 321123 321123 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recruitment

All colorectal cancer survivors who were treated and completed treatment at both study sites that met the eligibility criteria are recruited using convenience sampling. The comparability of the variables s is carried out to determine whether the study populations in both groups are similar. Next, the participants from Hospital Canselor Tuanku Muhriz will be allocated to the intervention group and participants from Hospital University Technology MARA will become the control group.

Intervention

The intervention group will perform Pilates exercises with a certified Pilates instructor for 60 minutes 3 sessions per week for eight weeks. The Pilates exercise programme is a moderate-intensity exercise with a heart rate maximum is 50-60% (Algayer et al. 2008) and corresponding to a rating of perceived exertion between 12 and 13 (ACSM, 2014) adapted from the study by Cantarero-Villanueva et al. (2016). Our expert panels consisting of sports medicine specialists, Pilates instructors, colorectal surgeons and physiotherapists already verified the exercise prescription is safe as an intervention among colorectal cancer survivors by
The Pilates exercise will start with a warm-up session then followed by the Pilates exercise. The Pilates exercise steps will be carried out in this study as follows;
1. One-leg stretch
i. Participants are lying down in a supine position and stretch one leg.
2. One-leg circle
i. Participants are lying down supine, stretching one leg and making circular movements using the stretched leg.
3. Bridging
i. Participants will lie on their back with hands at sides, knees bent and feet flat on the floor under the knees.
ii. Then tighten the abdominal and buttock muscles by pushing their low back into the ground before pushing up.
iii. Next, they will raise their hips to create a straight line between knees and shoulders. Then, squeeze their core and pull the belly button back toward their spine. Hold for 20 to 30 seconds and then return to starting position.
4. Dead bug resting
i. Participants are lying flat on their backs.
ii. Extend the arms and raise their feet, knees and hips.
iii. Then lower their opposite arms and legs simultaneously.
iv. Repeat with the other arm and leg.
5. Saw
i. Participants sit down on the exercise mat with both legs straight and arms flexed at 90 degrees.
ii. Then, participants will turn their body to the left and stretch the right hand to get as close as possible to the toes.
iii. This step is then repeated with the left hand.
The exercise is adapted to each participant's ability and tolerance. The participants will do the exercise via online streaming at the participants' homes in a group of sixteen (16) per session. The participants will be given a booklet that consists of exercise techniques and safety measures to be followed during the exercise. (This booklet is newly designed to act as a study manual specifically for this research). Besides that, we will give a video recording showing the demonstration of the exercise to the participants to ease them in following the activity. They are also provided with a polar heart rate sensor during the exercise to monitor their heart rate.
The exercise is adapted to each participant's ability and tolerance. Therefore, each participant will perform the exercise according to their capacity (i.e., stop and rest in between the steps or repetitions, drinking water). The instructor and facilitators will monitor the participants closely. The exercise is adapted to each participant's ability and tolerance. Adherence will be considered if they meet 75% of the session during the intervention period (Cantarero-Villanueva et al., 2016; Eyigor et al., 2010). The attendance for every session will be recorded in the attendance sheet by our researcher.
Intervention code [1] 321680 0
Rehabilitation
Intervention code [2] 321681 0
Lifestyle
Intervention code [3] 322210 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive usual care as stipulated by their oncologists during the study which consists of general recommendations on healthy lifestyle modifications such as maintaining ideal body weight, being physically active, consuming a healthy diet, limiting alcohol consumption and quit smoking.
Control group
Active

Outcomes
Primary outcome [1] 328901 0
The primary outcome will be quality of life level measured using EORTC QLQ-30 for general health questionnaire comprises of 30 items and have three components which are global health status (GHS) / global QoL, functional scales (FS) and symptom scales (SS). The GHS measure the overall health status and global QoL of the colorectal cancer patients which range from very bad (0) to excellent (7). The original QLQ-30 questionnaire English version had been validated with internal consistency of ranged within 0.70 to 0.90 and test-retest reliability >0.70 (Luckett et al., 2011). The Malay version of QLQ-30 had been validated with internal consistency ranged within 0.50 to 0.90 and test-retest reliability is 0.5 to 0.99 (Yusoff et al., 2010).
Timepoint [1] 328901 0
The measurement will be at the baseline followed by 8 weeks after the intervention.
Primary outcome [2] 328918 0
Colorectal cancer-specific quality of life will be measured using the EORTC QLQ-CR29, a tumour-specific questionnaire module for CRC patients to complement the EORTC QLQ-C30 questionnaire. The QLQ-CR29 has five functional and 18 symptom scales. The original CR-29 questionnaire English version had been validated with internal consistency ranged within 0.69 to 0.84 and test-retest reliability 0.53-0.77 (Whistance et al., 2009). The Malay version of CR-29 had been validated with internal consistency ranged within 0.66 to 0.778 and test-retest reliability is 0.79 to 0.93 (Magaji et al., 2016).
Timepoint [2] 328918 0
The measurement will be at the baseline followed by 8 weeks after the intervention.
Secondary outcome [1] 400828 0
Cancer-related fatigue will be measured using the FACT-Fatigue subscale (FACT-F) is a valid and reliable measure of fatigue intensity. The scores are totalled up from forty-one items from five domains; Physical well-being, Social/Family well-being, Emotional well-being, Functional well-being and Fatigue to become a total score that ranges from 0 to 52, with higher scores indicating less fatigue. In a 2007 study, the FACIT Fatigue Scale was found to have high internal validity (Cronbach’s alpha = 0.96) and high test-retest reliability (ICC = 0.95) (Chandran et al., 2007).
Timepoint [1] 400828 0
The measurement will be after 8 weeks of intervention.
Secondary outcome [2] 400830 0
Depression level will be measured using Patient Health Questionnaire – 9 (PHQ-9), a 9-items self-scored questionnaire presented in multiple-choice format to measure the presence and degree of depression. Responses consist of 4-Likert scale points from 0 to 3 whereby 3 represent the most severe symptoms. A higher score indicates a high level of depression. The internal reliability of the PHQ-9 was good, with a Cronbach's (alpha) of 0.67 and test-retest reliability was 0.73 (Azah et al., 2005)
Timepoint [2] 400830 0
The measurement will be after 8 weeks of intervention.
Secondary outcome [3] 400831 0
The salivary cortisol level will be analysed using enzyme-linked immunoassay (ELISA) kits (Banasik 2011). The participants will be taught how to collect the saliva at home.
Timepoint [3] 400831 0
The saliva will be collected using a saliva collection kit after waking up in the morning when they are still in bed (T1:6.00am), within 30 to 45 mins later (T2:6.30am to 6.45 am) and bedtime (T3:9.00pm) for two consecutive days at baseline and post-intervention 8 weeks.
Secondary outcome [4] 403095 0
Functional capacity will be assessed through a 6-minutes walk test. Participants are instructed to walk back and forth a 20-meter hallway for a period of 6 minutes at their fastest pace covering as much distance as possible during the allocated time. The score is the total distance walked in 6 min, measured in meters (Eyigor et al.,2010).
Timepoint [4] 403095 0
The measurement will be after 8 weeks of intervention.

Eligibility
Key inclusion criteria
1. Malaysian citizen or permanent residents age 18 to 65 years old.
2. Patients with a histologically confirmed diagnosis of colorectal cancer at Stage I, II and III treated at Hospital Canselor Tuanku Muhriz.
3. Completed all the curative treatment, surgery and chemotherapy/radiotherapy treatment within one year before the study enrollment.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Colorectal cancer patients that have developed metastasis and recurrent cancer.
2. Patients diagnosed with colorectal cancer as secondary cancer.
3. Colorectal cancer patients who suffer from hereditary colorectal cancer syndrome(s).
4. Have known limitations in Activities of Daily Living (ADL); eating, bathing, getting dressed, toileting, transferring and continence.
5. Diagnosed by specialists with musculoskeletal disorders (osteoarthritis, fibromyalgia, scoliosis or lower-back pain), ischemic heart disease and metabolic disorders.
6. Diagnosed by specialists with psychiatric illness, currently using psychiatric medication or receiving treatment for depression.
7. Diagnosed by specialists having chronic fatigue syndrome or currently using medication or receiving treatment for chronic fatigue syndrome.
8. History of neurological disorders (seizures, epilepsy etc.), urological problem (incontinence), abdominal hernia, autoimmune disease (SLE, rheumatoid arthritis).
9. Patients with a colostomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable anymore.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The estimated sample size for quality of life level was measured using the European Organisation Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire based on a randomized clinical trial study by Eyigor et al. (2010) among breast cancer survivors. The depression means score for the intervention group in the pre-intervention was 70.6 (20.58) and post-intervention was 77.02 (21.81). Meanwhile, the mean score was 62.64 (29.27) in pre-intervention and 63.78 (23.80) post-intervention in the comparison group. The mean difference score in the intervention group was 6.42 (1.23) and the mean difference score in the comparison group was 1.14 (-5.47). Therefore, the mean difference (d) between the intervention and control group was 5.28 points.
At a significant level of 0.05, power of 80% (Cohen, 1992) and the difference between two groups for at least 5.28 points with a standard deviation of 5, the sample size required for each group is 15 using PS sample size calculation program (Dupont & Plummer, 1990). After adjusting for attrition by 20 per cent, the minimum sample size required for each group is 18.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2022
Actual
16/07/2022
Date of last participant enrolment
Anticipated
7/08/2022
Actual
1/01/2023
Date of last data collection
Anticipated
30/09/2022
Actual
30/04/2023
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 24112 0
Malaysia
State/province [1] 24112 0
Selangor

Funding & Sponsors
Funding source category [1] 309649 0
University
Name [1] 309649 0
University Technology MARA
Country [1] 309649 0
Malaysia
Primary sponsor type
University
Name
University Technology MARA
Address
University Technology MARA, Campus Sungai Buloh,
Jalan Hospital,
47000 Sungai Buloh,
Selangor,
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 310663 0
None
Name [1] 310663 0
Address [1] 310663 0
Country [1] 310663 0
Other collaborator category [1] 281983 0
Hospital
Name [1] 281983 0
Hospital Canselor Tuanku Muhriz
Address [1] 281983 0
Jalan Yaacob Latif,
Bandar Tun Razak,
56000 Kuala Lumpur,
Wilayah Persekutuann,
MALAYSIA.
Country [1] 281983 0
Malaysia
Other collaborator category [2] 282376 0
Hospital
Name [2] 282376 0
Hospital Universiti Teknologi MARA (UiTM)
Address [2] 282376 0
Hospital Universiti Teknologi MARA (UiTM)
42300 Bandar Puncak Alam
Selangor.
Country [2] 282376 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309417 0
UiTM Research Ethics Committee
Ethics committee address [1] 309417 0
Ethics committee country [1] 309417 0
Malaysia
Date submitted for ethics approval [1] 309417 0
08/05/2020
Approval date [1] 309417 0
30/09/2020
Ethics approval number [1] 309417 0
REC 09/2020 (MR/288)
Ethics committee name [2] 309431 0
Medical Research Ethics Committee Hospital Canselor Tuanku Muhriz
Ethics committee address [2] 309431 0
Ethics committee country [2] 309431 0
Malaysia
Date submitted for ethics approval [2] 309431 0
30/10/2020
Approval date [2] 309431 0
29/03/2021
Ethics approval number [2] 309431 0
HTM-2021-009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114086 0
Dr Zahir Izuan Azhar
Address 114086 0
Department of Public Health Medicine
Faculty of Medicine
University Technology MARA
Sungai Buloh Campus
Jalan Hospital
47000 Sungai Buloh
Selangor
MALAYSIA
Country 114086 0
Malaysia
Phone 114086 0
+60361267228
Fax 114086 0
Email 114086 0
[email protected]
Contact person for public queries
Name 114087 0
Najibah Endut @ Abdul Razak
Address 114087 0
Department of Public Health Medicine
Faculty of Medicine
University Technology MARA
Sungai Buloh Campus
Jalan Hospital
47000 Sungai Buloh
Selangor
MALAYSIA
Country 114087 0
Malaysia
Phone 114087 0
+60192752740
Fax 114087 0
Email 114087 0
[email protected]
Contact person for scientific queries
Name 114088 0
Zahir Izuan Azhar
Address 114088 0
Department of Public Health Medicine
Faculty of Medicine
University Technology MARA
Sungai Buloh Campus
Jalan Hospital
47000 Sungai Buloh
Selangor
MALAYSIA
Country 114088 0
Malaysia
Phone 114088 0
+60361267228
Fax 114088 0
Email 114088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical ownership of the data belongs to the institutions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13182Ethical approval    382757-(Uploaded-13-09-2021-14-14-38)-Study-related document.pdf



Results publications and other study-related documents

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