Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000641493 |
Date of registration:
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17/05/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Supporting cancer survivors to stand up, sit less and move more
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Scientific title:
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A pilot study of a text message intervention to improve whole-of-day activity in cancer survivors participating in clinical exercise rehabilitation |
Date of first enrolment:
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15/03/2016 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000641493.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Sjaan Gomersall
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Address:
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School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Australia |
Telephone:
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+61 3365 3115 |
Email:
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s.gomersall1@uq.edu.au |
Affiliation:
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Name:
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Dr Sjaan Gomersall
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Address:
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School of Human Movement and Nutrition Sciences
The University of Queensland
Brisbane
QLD
4072
Australia |
Telephone:
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+61 7 3365 3115 |
Email:
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s.gomersall1@uq.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Participants have to opt in to the exercise clinic in order to be eligible for this study. articipation in the exercise clinic is optional for people with a previous diagnosis of cancer. To be included in the study, participants will have a previous diagnosis of cancer (excluding childhood cancers) and be at least one-month post surgery, with relevant information obtained from their medical practitioner (e.g. comorbidities, injuries, medications) to assist with exercise testing and prescription. Participants must also own a mobile phone.
Exclusion criteria: Participants will be excluded if they have established metastatic bone disease, or cardiopulmonary or metabolic disorders that will prevent safe participation in the testing or exercise sessions.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Cancer - Any cancer
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physical inactivity;sedentary behaviour;cancer survivorship; physical inactivity sedentary behaviour cancer survivorship
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Public Health - Health promotion/education
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Intervention(s)
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All participants will attend a 4-week exercise clinic for cancer surivors. Participation in the exercise clinic is optional for people with a previous diagnosis of cancer. Participants will be prescribed 1 h, individualized, supervised exercise sessions once weekly for 4 weeks. Participants will be encouraged to increase their physical activity levels outside of the exercise sessions. All testing and training sessions will be conducted in the School of Human Movement and Nutrition Sciences Gymnasium. Participants are individually supervised (see below) in groups of up to 10 participants. Participants will complete sessions prescribed by final year clinical exercise physiology students in a 2:1 student:participant ratio supervised by Accredited Exercise Physiologists in a 1:2 AEP:participant ratio. The exercise program will be individualized to address participant goals, preferences, medical history and initial assessment results. Each 1 h session included: low intensity aerobic warm-up (5–10 min); four to six progressive upper and lower body resistance exercises of 10–12RM (targeting the chest, biceps, triceps, quadriceps, hamstrings and latissimus dorsi muscle groups) using machine, free weights and/or resistance bands; balance activities; low intensity aerobic cool down (5–10 min); static muscle stretching activities; and education on the benefits of exercise for health. Resistance load was increased by 5–10 percent when participants exceeded the prescribed RM. Accredited exercise physiologists will record attendance and any adverse (i.e. any untoward medical occurrence occurring during the exercise sessions), or serious adverse events (i.e. adverse events that are still ongoing at the end of the study period).
In addition to participating in the 4-week exercis
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Primary Outcome(s)
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Overall sitting time per day (h/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Secondary Outcome(s)
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Quality of life measured using the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Exercise capacity measured using the 400m walk test[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Grip strength will be measured using a spring-loaded grip dynamometer for the dominant hand. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Anthropometry measured using waist circumference, height and weight. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Stepping time (overall and at slow and fast cadence) (min/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Prolonged sitting time (>30 mins) (h/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Acceptability - assessed using a purpose-designed survey to examine participants' perception of intervention[12-weeks post commencement of intervention. ]
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Muscular strength measured using 1RM method for leg press. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Balance will be measured using a timed tandem stance[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Acceptability of the intervention assessed using a purpose designed survey[12-week follow up]
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Feasibility - assessed using attendance at coaching sessions and text analytics (number of SMS sent/received)[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Resting blood pressure will be measured using a sphygmomanometer after 5 min of seated rest[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Physical function measured using a repeated chair stand and usual gait speed [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Standing time (min/day) measured using the activPAL3, a valid thigh-worn accelerometer. The monitor will be worn for 7 consecutive days at each measurement occasion. [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Resting heart rate will be measured after 5 min of seated rest using a Polar Heart Rate Monitor[At baseline, 4- and 12-weeks post commencement of intervention. ]
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Use of time (min/day; Sleep, Screen, Quiet Time, Social, Self-Care, Work,
Transport, Chores, Physical Activity) measured using the Multimedia Activity Recall for Children and Adults, a computerised time use recall tool. This will be administered to participants via computer assisted telephone interview (CATI). [At baseline, 4- and 12-weeks post commencement of intervention. ]
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Source(s) of Monetary Support
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The University of Queensland
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Ethics review
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Status: Approved
Approval date:
Contact:
School of Human Movement and Nutrition Sciences, The University of Queensland Ethics
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Results
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Results available:
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Yes |
Date Posted:
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23/04/2019 |
Date Completed:
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01/09/2016 |
URL:
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