Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000749505
Ethics application status
Approved
Date submitted
10/05/2024
Date registered
17/06/2024
Date last updated
17/06/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Exercise Intervention on Cancer-Related Fatigue Among Cervical Cancer Patients
Scientific title
Effect of Exercise Intervention on Cancer-Related Fatigue, Exercise Self-Efficacy and Physical Function Among Cervical Cancer Patients
Secondary ID [1] 312099 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-Related Fatigue in Cervical Cancer Patients 333734 0
Condition category
Condition code
Cancer 330415 330415 0 0
Cervical (cervix)
Physical Medicine / Rehabilitation 330416 330416 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Six-week exercise training, alternating between supervised session at hospital and home-based session.

Supervised exercise session will be conducted once a week in the first, third, and fifth week, in a group consisting of three to five participants supervised by one researcher (physiotherapist). Each exercise session will be conducted approximately 20 to 30 minutes, starting with a warm-up session, followed by aerobic and resistance exercises, ending with a cool-down session. Participants are advised to do exercise activities according to their own pace and allowed to take short rest periods at any time before resuming exercise activities during the exercise session. The exercise intervention aimed to reach the intensity of low to moderate which is 55 to 75 percent of maximum heart rate or rate of perceived exertion (RPE) between 11 to 14. The number of sets and intensity will be gradually increased throughout the intervention weeks following participants’ capability. Blood pressure and heart rate will be recorded at the beginning and end of each session, while during the exercise, RPE value will be monitored using Borg scale to maintain low- to moderate-exercise intensity.

Home-based exercise session will be performed in the second, fourth, and sixth week with online supervision (if needed) through participants’ preferred method (such as 'WhatsApp', 'Telegram', or phone calls). Exercise components will consist of the same exercise from the supervised exercise session of the preceding week to enhance adherence and sustainability to the exercise routine. Through this method, participants may feel more confident in exercising as they will be taught proper exercise techniques during the supervised exercise session and just continuing what have been taught at home during home-based exercise session. Exercise handout will be given as a guide while exercising at home. (This exercise handout is specifically designed for this research which consist of exercise techniques and also as an exercise diary for participants to record their exercise session.) Participants are advised to exercise at home for at least three times a week for 30 minutes each session, or at least engage in exercise for 150 minutes per week. They are free to exercise at any time throughout the home-based exercise week or whenever they feel their fatigue level at the lowest. The exercise intensity of low to moderate will be self-monitored by the participants through RPE value using Borg scale between 11 to 14 and through the talk test, where they can still talk but cannot sing while exercising.

Below are exercise component of every week for six weeks:

Week 1 (Supervised exercise) & Week 2 (Home-based exercise)
Warming-up session:
- Breathing control exercise; 5x, 1 set
- Shoulder roll; 5x, 1 set
- Seated leg lift; 5x, 1 set
- Seated leg tap-out reach; 5x, 1 set
Strengthening exercise:
- Seated heel raise; 5x, 2 sets
- Seated leg extension; 5x, 2 sets
- Sit-to-Stand/Squatting; 5x, 2 sets
Aerobic exercise:
- Seated jack; 30 secs, 1 set
- Seated marching; 30 secs, 1 set
- Step-ups; 30 secs, 1 set
Cool down session:
- Deep breathing exercise; 3x, 1 set
- Shoulder stretch; 15 sec holds, 3x, 1 set
- Chest stretch; 15 sec holds, 3x, 1 set
- Calf stretch; 15 sec holds, 3x, 1 set
- Quads stretch; 15 sec holds, 3x, 1 set
- Hamstring stretch; 15 sec holds, 3x, 1 set

Week 3 (Supervised exercise) & Week 4 (Home-based exercise)
Warming up session:
- Breathing control exercise; 5x, 1 set
- Shoulder roll (progress with hands on shoulder and circle the elbows); 5x, 1 set
- Standing leg lift; 5x, 1 set
- Standing leg tap-out reach; 5x, 1 set
Strengthening exercise:
- Arm supported heel raise; 10x, 2 sets
- Seated leg extension (both); 5x, hold 3-5 sec, 2 sets
- Sit-to-Stand/Squatting; 10x, 2 sets
Aerobic exercise:
- Star jacks; 30 secs, 2 set
- Marching; 30 secs, 2 set
- Step-ups; 30 secs, 2 set
Cool down session:
- Deep breathing exercise; 3x, 1 set
- Shoulder stretch; 15 sec holds, 3x, 1 set
- Chest stretch; 15 sec holds, 3x, 1 set
- Calf stretch; 15 sec holds, 3x, 1 set
- Quads stretch; 15 sec holds, 3x, 1 set
- Hamstring stretch; 15 sec holds, 3x, 1 set

Week 5 (Supervised exercise) & Week 6 (Home-based exercise)
Warming up session:
- Breathing control exercise; 5x, 1 set
- Shoulder roll (progress with arms extended and circle the arm); 5x, 1 set
- Standing leg lift; 5x, 2 sets
- Standing leg tap-out reach; 5x, 2 sets
Strengthening exercise:
- Heel raise; 10x, 3 sets
- One-leg standing; 5x, hold 3-5 sec, 2 sets
- Sit-to-Stand/Squatting; 10x, 3 sets
Aerobic exercise:
- Side walking; 1 min, 2 sets
- Standing knee lift; 1 min, 2 sets
- Step-ups; 1 min, 2 sets
- Walking back and forth; 1 min, 2 sets
Cool down session:
- Deep breathing exercise; 3x, 1 set
- Shoulder stretch; 15 sec holds, 3x, 1 set
- Chest stretch; 15 sec holds, 3x, 1 set
- Calf stretch; 15 sec holds, 3x, 1 set
- Quads stretch; 15 sec holds, 3x, 1 set
- Hamstring stretch; 15 sec holds, 3x, 1 set
Intervention code [1] 328544 0
Treatment: Other
Intervention code [2] 328545 0
Rehabilitation
Intervention code [3] 328549 0
Lifestyle
Comparator / control treatment
Participants in control group will receive standard care provided by the hospital/oncologist. This care includes general advice on healthy lifestyle changes such as staying physically active and eating a nutritious diet.
Control group
Active

Outcomes
Primary outcome [1] 338178 0
Fatigue
Timepoint [1] 338178 0
Baseline, Post-intervention (Week-7: Primary endpoint), 4 weeks after post-intervention (Week-11)
Primary outcome [2] 338179 0
Aerobic endurance
Timepoint [2] 338179 0
Baseline, Post-intervention (Week-7: Primary endpoint), 4 weeks after post-intervention (Week-11)
Primary outcome [3] 338377 0
Strength of lower limbs
Timepoint [3] 338377 0
Baseline, Post-intervention (Week-7: Primary endpoint), 4 weeks after post-intervention (Week-11)
Secondary outcome [1] 434824 0
Exercise Self-Efficacy
Timepoint [1] 434824 0
Baseline, Post-intervention (Week-7: Primary endpoint), 4 weeks after post-intervention (Week-11)

Eligibility
Key inclusion criteria
1. Malaysian citizen
2. Can communicate in English/Malay
3. Patient diagnosed with cervical cancer stage I - III treated at Hospital Canselor Tuanku Muhriz
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of previous/recurrent cancer
2. Diagnosed with peripheral neuropathy issues
3. Diagnosed with cardiovascular disease
4. Non-ambulatory/walking with assistance
5. Fatigue score 0-3 (Using Revised Piper Fatigue Scale)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be done at a 1:1 ratio using computer-generated random sequence with stratification based on the total score of Revised Piper Fatigue Scale measured at baseline (4-6 = mild fatigue, 7-10 = severe fatigue).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was determined using G*Power 3.1.9.4 with 80 percent power, significance level of 5 percent, and effect size of 0.5. The effect size was calculated based on previous studies where the mean fatigue level ± standard deviation of the experimental and control groups were 5.56 ± 1.74 and 7.52 ± 1.89 respectively (Darvishi et al. 2023). The minimum sample size required is 48 for both groups. However, attrition rate has been estimated at 10 percent over the six-week exercise sessions, making the overall attrition rate 60 percent. High attrition rate has been taken into account due to the frequency of follow-up face-to-face visits and the possibility that participants may not be able to adhere to the exercise routine due to the severity of their fatigue symptoms, or they may need to be transferred to another hospital, or they may pass away during the study period. Therefore, after considering a 60 percent attrition rate, the total sample size will be 78 for both of the exercise and control groups with a 1:1 ratio.

Statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) software. Demographic data, level of cancer-related fatigue and exercise self-efficacy will be reported in mean and standard deviation using descriptive analysis. If the data distribution is normal, the parametric test Repeated-Measures Analysis of Covariance (ANCOVA) will be used to investigate the effect of exercise intervention on cancer-related fatigue and physical function with measurements (baseline, post-intervention, 4 weeks after post-intervention) as within-subject variables, groups (exercise group, control group) as between-subject variables, and exercise self-efficacy as a covariate. However, if the data distribution is not normal, the non-parametric test Friedman Test will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment outside Australia
Country [1] 26295 0
Malaysia
State/province [1] 26295 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 316456 0
University
Name [1] 316456 0
National University of Malaysia
Country [1] 316456 0
Malaysia
Primary sponsor type
University
Name
National University of Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 318630 0
Individual
Name [1] 318630 0
Associate Professor Dr. Caryn Mei Hsien Chan
Address [1] 318630 0
Country [1] 318630 0
Malaysia
Secondary sponsor category [2] 318826 0
Individual
Name [2] 318826 0
Professor Dr. Mohamad Nasir bin Shafiee
Address [2] 318826 0
Country [2] 318826 0
Malaysia
Secondary sponsor category [3] 318827 0
Individual
Name [3] 318827 0
Associate Professor Dr. Nor Azlin binti Mohd Nordin
Address [3] 318827 0
Country [3] 318827 0
Malaysia
Secondary sponsor category [4] 318828 0
Individual
Name [4] 318828 0
Nabila Afiqah binti Tuan Rusli
Address [4] 318828 0
Country [4] 318828 0
Malaysia
Other collaborator category [1] 283029 0
Hospital
Name [1] 283029 0
Hospital Canselor Tuanku Muhriz
Address [1] 283029 0
Country [1] 283029 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315247 0
National University of Malaysia Research Ethics Committee
Ethics committee address [1] 315247 0
Ethics committee country [1] 315247 0
Malaysia
Date submitted for ethics approval [1] 315247 0
10/01/2024
Approval date [1] 315247 0
12/06/2024
Ethics approval number [1] 315247 0
UKM PPI/111/8JEP-2024-184

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

Contacts
Principal investigator
Name 134122 0
A/Prof Caryn Mei Hsien Chan
Address 134122 0
Department of Health Psychology and Behaviour, Faculty of Health Science, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 134122 0
Malaysia
Phone 134122 0
+60163090771
Fax 134122 0
Email 134122 0
[email protected]
Contact person for public queries
Name 134123 0
Nabila Afiqah Tuan Rusli
Address 134123 0
Faculty of Health Science, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 134123 0
Malaysia
Phone 134123 0
+60193265754
Fax 134123 0
Email 134123 0
[email protected]
Contact person for scientific queries
Name 134124 0
Nabila Afiqah Tuan Rusli
Address 134124 0
Faculty of Health Science, National University of Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country 134124 0
Malaysia
Phone 134124 0
+60193265754
Fax 134124 0
Email 134124 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23895Ethical approval    387766-(Uploaded-14-06-2024-17-59-49)-Ethical Approval Letter.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.