Supervised Physical Activity Plus Exercise CounselingPhase 2TRACKSNCT01571401
Trying Activity in Kidney Cancer Survivors (TRACKS) Trial
A Phase 2 study testing Trying Activity for Kidney Cancer Survivors (TRACKS) Trial in people with Supervised Physical Activity Plus Exercise Counseling and Supervised Physical Activity Plus Behavioural Counseling, run by University of Alberta at 1 site in Canada.
Trial summary
Objectives: The purpose of this study is to find out if a new program can help kidney cancer survivors (KCS) increase their physical activity (PA) and improve their quality of life (QoL). Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Supervised Physical Activity Plus Exercise Counseling, Supervised Physical Activity Plus Behavioural Counseling
- What is being tested?
- Trying Activity for Kidney Cancer Survivors (TRACKS) Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Screening evaluations will be conducted on interested participants and eligibility criteria include the following: a) between the ages of 18 to 80 years of age, histologically confirmed kidney cancer (Stage I-IIIa); b) ability and willingness to effectively communicate with the study coordinator and complete all questionnaires involved in the study in English; c) able to attend the supervised PA sessions and not planning to be away for three consecutive days for the duration of the program; and d) interested in increasing their PA by at least 60 minutes of moderate PA or 30 minutes of vigorous PA. Following the screening procedure and prior to randomization, consenting participants that are deemed eligible will undergo submaximal exercise testing to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Two stages of the treadmill test must be successfully completed with acceptable heart rate and blood pressure responses before any remaining baseline tests will be conducted including a physical function test, anthropometric testing, and PA behaviour, quality of life, and determinants questionnaire.
Who cannot join
- The researchers can remove the participants from the study early for reasons such as a cancer recurrence, doctor feels that the participant is unable to participate in a physical activity program and/or participate in the follow up fitness testing, and/or two stages of the treadmill test cannot be completed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trying Activity in Kidney Cancer Survivors (TRACKS) Trial: A Randomized Controlled Trial Comparing the Effects of Supervised Physical Activity Versus Supervised Physical Activity Plus Behavioural Counselling
Objectives: The purpose of this study is to find out if a new program can help kidney cancer survivors (KCS) increase their physical activity (PA) and improve their quality of life (QoL).
Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry. Participants will undergo submaximal exercise testing, a physical function test and measures of height and weight, which will be completed at baseline and the end of the physical activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of the entire program (at 12 weeks). Following baseline assessments, participants will be randomly assigned to either: (1) supervised physical activity plus traditional exercise counseling or (2) supervised physical activity plus behavioural counseling. Participants will be asked to attend six individual supervised exercise and counseling sessions over a 4-week period with a PA specialist that eventually tapers to a home-based program by the end of the program.
Implications: The investigators hope that this PA intervention for KCS is feasible and results in meaningful improvements in health outcomes that can be translated to public health practice.
Read the detailed description
Background: Despite the reported benefits of physical activity (PA), the majority of cancer survivors are not meeting public health PA guidelines. Most PA intervention studies have used supervised exercise and demonstrated benefits. However, these studies have also found that PA declines significantly after the supervised intervention is completed. Consequently, interventions are needed to ensure longer term adherence after short term supervised exercise interventions. Although several of behaviour change interventions have supported positive increases in PA, no study to date has examined the effects of adding behavioural counseling to a standard supervised exercise program and no study has focused on kidney cancer survivors (KCS).
Objectives: The primary purpose of the Trying Activity in Kidney Cancer Survivors (TRACKS) Trial is to compare the effects of a supervised physical activity program plus traditional exercise counseling (SPA) versus a supervised physical activity plus motivationally-enhanced behavioural counseling (SPA+BC) on change in self-reported moderate/vigorous PA between baseline, post-intervention, and 12-week follow-up among KCS. The secondary outcomes are changes in self-reported quality of life (QoL), body composition (anthropometric measures), cardiorespiratory fitness, physical function, and motivational constructs from the Theory of Planned Behaviour (TPB) constructs.
Methods: The study will pilot a two-armed, randomized controlled trial of 50 KCS. KCS will be recruited from a previous study using the Alberta Cancer Registry. Eligibility will include: a) between 18-80 years of age, b) diagnosed with Stage I-IIIa kidney cancer, and g) interested in increasing their physical activity. Following the screening procedure and prior to randomization, participants will undergo submaximal exercise testing on a treadmill to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Randomization will occur after all baseline measurements have been completed. The goal of the intervention, based on current public health recommendations, will be to gradually increase all participants by at least 60 minutes of moderate intensity PA or 30 minutes of vigorous intensity PA to a minimum of 150 minutes of moderate intensity PA or 75 minutes of vigorous intensity PA per week. Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Participants assigned to the SPA group will be given an individualized prescription at a moderate-to-vigorous intensity. They will also receive traditional exercise counseling to teach proper PA technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guidelines. For the SPA+BC group, participants will receive the same supervised PA sessions with the addition of six individual "face-to-face" behavioural counseling sessions with a physical activity specialist. These behaviour counseling sessions will include training in behavioural strategies to promote the adoption and long-term maintenance of PA. Measurements for the primary and secondary endpoints will be assessed at baseline (pre-intervention), 4 weeks (post-intervention), and 12 weeks follow-up.
Conclusion: The study results can be used to determine if a behavior change intervention for KCS based on the TPB results in potentially meaningful improvements in PA and selected health outcomes.
- Conditions
- Supervised Physical Activity Plus Exercise Counseling, Supervised Physical Activity Plus Behavioural Counseling
- Being tested
- Trying Activity for Kidney Cancer Survivors (TRACKS) Trial
- Keywords
- Kidney cancer survivors, Randomized Controlled Trial, Physical Activity, Theory of Planned Behaviour, Quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trying Activity for Kidney Cancer Survivors (TRACKS) TrialBehavioural
Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, both groups will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at the Behavioural Medicine Fitness Centre at the University of Alberta. In order to achieve the PA guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Supervised PA plus Exercise Counselling | Experimental | Participants will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, this group will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at fitness centre. In order to achieve the physical activity guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed. In addition to the supervised sessions, traditional exercise counselling will be provided to teach proper technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health physical activity guidelines Receives: Behavioral: Trying Activity for Kidney Cancer Survivors (TRACKS) Trial |
| Supervised PA plus behavioural counselling | Experimental | In addition to the same supervised PA sessions as the SPA group, participants in this group will receive six individual "face-to-face" behavioural counselling sessions with a physical activity specialist. These counselling sessions will be combined with the supervised PA sessions, and will be provided directly following the supervised PA session. Counselling strategies will be based on the TPB and will target the unique benefits of PA for kidney cancer survivors, strategies for making PA enjoyable, for overcoming barriers, for including social support from family and friends, time management, self-monitoring, goal setting, and planning. Receives: Behavioral: Trying Activity for Kidney Cancer Survivors (TRACKS) Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported moderate/vigorous physical activity
A modified version of the validated Leisure Score Index (LSI) from the Godin Leisure-Time Exercise Questionnaire (GLTEQ), that has been extensively validated, will be used to assess PA behavior. Participants will be asked to recall their average weekly frequency and duration of light (minimal effort, no perspiration), moderate (not exhausting, light perspiration), and vigorous (heart beats rapidly, sweating) PA that lasted at least 10 minutes and was done during free time in the past month.
Measured: 12 weeks
Secondary outcomes (5)
Quality of life (QoL)
Disease-specific QoL will be assessed by the well-validated Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale which includes the 27 items from the FACT-General (FACT-G) scale plus the 13 item fatigue subscale.
Generic QoL will also be assessed using the RAND (Research and Development)-36 Health Status Inventory, which contains 36 items that yield eight health domains with multi-item scales.
Measured: 12 weeks
Theory of Planned Behaviour (TPB)
TPB items will be assessed by asking questions related to instrumental and affective attitude, descriptive and injunctive norms, perceived behavioural control, intention, and planning using a likert-type response format.
Measured: 12 weeks
Anthropometric measures
Measurements of height, weight, and circumferences will be used to estimate body composition. Height will be measured using a stadiometer to the nearest 0.1 cm. Weight will be measured using a balance beam scale to the nearest 0.1 kg. Height and weight will be used to calculate body mass index (BMI) [weight per height squared (kg/m²)].
Measured: 12 weeks
cardiorespiratory fitness
Participants will undergo sub-maximal aerobic testing to assess aerobic fitness and estimate VO2max from simple heart rate measurements. The test used will be a modified Balke Test performed on a treadmill to 85% of their maximal heart rate or exhaustion.
Measured: 12 weeks
physical function
The Seniors' Fitness Test (SFT) will be used to assess physical fitness/function in older adults aged 60 to 90+ years old. The SFT consists of a battery of six assessment items used to determine mobility-related fitness parameters.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supervised Physical Activity Plus Exercise CounselingStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Trinh, MA, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571401
- Sponsor's protocol ID
- TRACKS Trial for Kidney Cancer
- Acronym
- TRACKS
- Status last verified
- Apr 2012
- First submitted
- 2 Apr 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Associations between physical activity and quality of life in a population-based sample of kidney cancer survivors. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):859-68. doi: 10.1158/1055-9965.EPI-10-1319. Epub 2011 Apr 5.
PubMed 21467240Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Physical activity preferences in a population-based sample of kidney cancer survivors. Support Care Cancer. 2012 Aug;20(8):1709-17. doi: 10.1007/s00520-011-1264-z. Epub 2011 Sep 24.
PubMed 21947412
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trying Activity in Kidney Cancer Survivors (TRACKS) Trial: A Randomized Controlled Trial Comparing the Effects of Supervised Physical Activity Versus Supervised Physical Activity Plus Behavioural Counselling
- ClinicalTrials.gov ID
- NCT01571401
- Acronym / sponsor ID
- TRACKS / TRACKS Trial for Kidney Cancer
- Conditions
- Supervised Physical Activity Plus Exercise Counseling, Supervised Physical Activity Plus Behavioural Counseling
- Keywords
- Kidney cancer survivors, Randomized Controlled Trial, Physical Activity, Theory of Planned Behaviour, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The purpose of this study is to find out if a new program can help kidney cancer survivors (KCS) increase their physical activity (PA) and improve their quality of life (QoL).
Methods: Fifty KCS will be recruited from a previous study using the Alberta Cancer Registry. Participants will undergo submaximal exercise testing, a physical function test and measures of height and weight, which will be completed at baseline and the end of the physical activity program (at 12 weeks). Participants will also complete questionnaires on PA and QoL at the baseline, after the supervised portion of the program (at 4 weeks), and at the end of the entire program (at 12 weeks). Following baseline assessments, participants will be randomly assigned to either: (1) supervised physical activity plus traditional exercise counseling or (2) supervised physical activity plus behavioural counseling. Participants will be asked to attend six individual supervised exercise and counseling sessions over a 4-week period with a PA specialist that eventually tapers to a home-based program by the end of the program.
Implications: The investigators hope that this PA intervention for KCS is feasible and results in meaningful improvements in health outcomes that can be translated to public health practice.
Detailed description
Background: Despite the reported benefits of physical activity (PA), the majority of cancer survivors are not meeting public health PA guidelines. Most PA intervention studies have used supervised exercise and demonstrated benefits. However, these studies have also found that PA declines significantly after the supervised intervention is completed. Consequently, interventions are needed to ensure longer term adherence after short term supervised exercise interventions. Although several of behaviour change interventions have supported positive increases in PA, no study to date has examined the effects of adding behavioural counseling to a standard supervised exercise program and no study has focused on kidney cancer survivors (KCS).
Objectives: The primary purpose of the Trying Activity in Kidney Cancer Survivors (TRACKS) Trial is to compare the effects of a supervised physical activity program plus traditional exercise counseling (SPA) versus a supervised physical activity plus motivationally-enhanced behavioural counseling (SPA+BC) on change in self-reported moderate/vigorous PA between baseline, post-intervention, and 12-week follow-up among KCS. The secondary outcomes are changes in self-reported quality of life (QoL), body composition (anthropometric measures), cardiorespiratory fitness, physical function, and motivational constructs from the Theory of Planned Behaviour (TPB) constructs.
Methods: The study will pilot a two-armed, randomized controlled trial of 50 KCS. KCS will be recruited from a previous study using the Alberta Cancer Registry. Eligibility will include: a) between 18-80 years of age, b) diagnosed with Stage I-IIIa kidney cancer, and g) interested in increasing their physical activity. Following the screening procedure and prior to randomization, participants will undergo submaximal exercise testing on a treadmill to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Randomization will occur after all baseline measurements have been completed. The goal of the intervention, based on current public health recommendations, will be to gradually increase all participants by at least 60 minutes of moderate intensity PA or 30 minutes of vigorous intensity PA to a minimum of 150 minutes of moderate intensity PA or 75 minutes of vigorous intensity PA per week. Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Participants assigned to the SPA group will be given an individualized prescription at a moderate-to-vigorous intensity. They will also receive traditional exercise counseling to teach proper PA technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guidelines. For the SPA+BC group, participants will receive the same supervised PA sessions with the addition of six individual "face-to-face" behavioural counseling sessions with a physical activity specialist. These behaviour counseling sessions will include training in behavioural strategies to promote the adoption and long-term maintenance of PA. Measurements for the primary and secondary endpoints will be assessed at baseline (pre-intervention), 4 weeks (post-intervention), and 12 weeks follow-up.
Conclusion: The study results can be used to determine if a behavior change intervention for KCS based on the TPB results in potentially meaningful improvements in PA and selected health outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised PA plus Exercise Counselling | Experimental | Behavioral: Trying Activity for Kidney Cancer Survivors (TRACKS) TrialParticipants will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, this group will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at fitness centre. In order to achieve the physical activity guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed. In addition to the supervised sessions, traditional exercise counselling will be provided to teach proper technique, how to monitor intensity, and to progress PA safely and effectively to achieve the public health physical activity guidelines |
| Supervised PA plus behavioural counselling | Experimental | Behavioral: Trying Activity for Kidney Cancer Survivors (TRACKS) TrialIn addition to the same supervised PA sessions as the SPA group, participants in this group will receive six individual "face-to-face" behavioural counselling sessions with a physical activity specialist. These counselling sessions will be combined with the supervised PA sessions, and will be provided directly following the supervised PA session. Counselling strategies will be based on the TPB and will target the unique benefits of PA for kidney cancer survivors, strategies for making PA enjoyable, for overcoming barriers, for including social support from family and friends, time management, self-monitoring, goal setting, and planning. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Screening evaluations will be conducted on interested participants and eligibility criteria include the following: a) between the ages of 18 to 80 years of age, histologically confirmed kidney cancer (Stage I-IIIa); b) ability and willingness to effectively communicate with the study coordinator and complete all questionnaires involved in the study in English; c) able to attend the supervised PA sessions and not planning to be away for three consecutive days for the duration of the program; and d) interested in increasing their PA by at least 60 minutes of moderate PA or 30 minutes of vigorous PA. Following the screening procedure and prior to randomization, consenting participants that are deemed eligible will undergo submaximal exercise testing to ensure that they are able to exercise safely at a moderate-to-vigorous intensity. Two stages of the treadmill test must be successfully completed with acceptable heart rate and blood pressure responses before any remaining baseline tests will be conducted including a physical function test, anthropometric testing, and PA behaviour, quality of life, and determinants questionnaire.
Key exclusion criteria (1 listed)
- The researchers can remove the participants from the study early for reasons such as a cancer recurrence, doctor feels that the participant is unable to participate in a physical activity program and/or participate in the follow up fitness testing, and/or two stages of the treadmill test cannot be completed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trying Activity for Kidney Cancer Survivors (TRACKS) TrialParticipants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, both groups will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at the Behavioural Medicine Fitness Centre at the University of Alberta. In order to achieve the PA guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed. | Behavioural | Supervised PA plus Exercise Counselling, Supervised PA plus behavioural counselling |
Primary outcome
self-reported moderate/vigorous physical activity
Time frame: 12 weeks
A modified version of the validated Leisure Score Index (LSI) from the Godin Leisure-Time Exercise Questionnaire (GLTEQ), that has been extensively validated, will be used to assess PA behavior. Participants will be asked to recall their average weekly frequency and duration of light (minimal effort, no perspiration), moderate (not exhausting, light perspiration), and vigorous (heart beats rapidly, sweating) PA that lasted at least 10 minutes and was done during free time in the past month.
5 secondary outcomes
Quality of life (QoL)
Time frame: 12 weeks
Theory of Planned Behaviour (TPB)
Time frame: 12 weeks
Anthropometric measures
Time frame: 12 weeks
cardiorespiratory fitness
Time frame: 12 weeks
physical function
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Background: PubMed 21467240Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Associations between physical activity and quality of life in a population-based sample of kidney cancer survivors. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):859-68. doi: 10.1158/1055-9965.EPI-10-1319. Epub 2011 Apr 5.
- Background: PubMed 21947412Trinh L, Plotnikoff RC, Rhodes RE, North S, Courneya KS. Physical activity preferences in a population-based sample of kidney cancer survivors. Support Care Cancer. 2012 Aug;20(8):1709-17. doi: 10.1007/s00520-011-1264-z. Epub 2011 Sep 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Trinh, MA principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trying Activity for Kidney Cancer Survivors (TRACKS) Trial in people with Supervised Physical Activity Plus Exercise Counseling and Supervised Physical Activity Plus Behavioural Counseling, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported moderate/vigorous physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.