StrokePhase 4NCT02798237
Effects of Aerobic Training Post-stroke
A Phase 4 study testing Aerobic treadmill training in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic treadmill training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Dec 2017to 15 Oct 2018
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 20years of age;
- diagnosis of stroke (>6months);
- sedentary or insufficiently active;
- have a writing medical permission to participate in the training program.
Who cannot join
- cognitive impairment (Mini-Mental Status Examination score: illiterate 13 points; elementary and middle school 18 points; and high-school 26 points; or inability to respond to verbal command);
- inability to walk independently for at least 10 minutes, with or without walking devices;
- pain or other disorders precluding their participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial
Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.
A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.
The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.
Read the detailed description
The sample size has been calculated considering the physical activity levels measured by the Human Activity Profile (HAP). The effect size has been derived from the study of Teixeira-Salmela et al. 1999, who performed aerobic training in addition to lower limbs resistance training, and home exercises with subjects with chronic stroke. The experimental group (n=6) showed an increase on HAP on average of 20±6.1 points after the intervention, and the control group (n=7) had an average reduction of 1.86±0.19 points. Considering a significance level of 5% and a desired power of 80%, 9 participants per group was found, or 18 participants in total. Assuming an expected dropout rate of 20%, a target of 22 participants in total was set (11 participants per group).
Statistical analyses: A code will be given to each participant. Two independent examiners, blinded to the group allocation, will perform data entry, and verify missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. An independent examiner, blinded to the group allocation, will perform the statistical analysis by SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be performed for all outcome variables. Baseline variables will be compared between groups using independent Student's t-tests, to investigate differences among the groups regarding the clinical-demographical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors. The effects of the interventions will be analyzed from the collected data and the intention-to-treat analysis. Data from the last available assessment will be considered as the values of missed sessions. Between-groups differences will be measured with two-way ANOVA with repeated measures considering the baseline, post-training, and follow-up measures. Level of significance will be set at 0.05 and adjusted for multiple comparisons. Normality and equality of variance will also be analyzed to ensure correct use of parametric data. Study results will be spread regardless of the magnitude and direction of the effects.
- Conditions
- Stroke
- Being tested
- Aerobic treadmill training, Control (overground walking)
- Keywords
- exercise, walking, health
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic treadmill trainingOther
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.
Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill.
Control (overground walking)Other
Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the exercise, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program
| Study group | Role | What they receive |
|---|---|---|
| Aerobic treadmill training | Experimental | Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.
Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill. Receives: Other: Aerobic treadmill training |
| Control (overground walking) | Sham comparator | Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Receives: Other: Control (overground walking) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical activity levels - multisensor monitor
Physical activity levels will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Physical activity levels - Human Activity Profile
Physical activity levels will be assessed by Human Activity Profile
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in sedentary behavior - multisensor monitor
Sedentary behavior will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Secondary outcomes (7)
Change from baseline in Cardiorespiratory fitness - cardiopulmonary exercise test
Cardiorespiratory fitness will be assessed by cardiopulmonary exercise test
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - six minute walk test
Endurance will be assessed by six minute walk test
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - shuttle walk test
Endurance will be assessed by shuttle walk test
Measured: At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Depression - Patient Health Questionnaire (PHQ-2 and PHQ-9)
Depression will be assessed by Patient Health Questionnaire (PHQ-2 and PHQ-9)
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Mobility - gait speed
Mobility will be assessed by gait speed
Measured: At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Quality of life - Stroke specific quality of life
Quality of life will be assessed by Stroke specific quality of life
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Participation - Stroke impact scale
Participation will be assessed by (Stroke impact scale)
Measured: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start4 Dec 2017
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
- Investigators
- Christina Faria, Ph.D., Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798237
- Sponsor's protocol ID
- CAAE:51454115.6.0000.5149
- Status last verified
- May 2019
- First submitted
- 6 Jun 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pang MY, Charlesworth SA, Lau RW, Chung RC. Using aerobic exercise to improve health outcomes and quality of life in stroke: evidence-based exercise prescription recommendations. Cerebrovasc Dis. 2013;35(1):7-22. doi: 10.1159/000346075. Epub 2013 Feb 14.
PubMed 23428993Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
PubMed 24846875Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
PubMed 34184251Aguiar LT, Nadeau S, Britto RR, Teixeira-Salmela LF, Martins JC, Faria CDCM. Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial. Trials. 2018 Aug 17;19(1):446. doi: 10.1186/s13063-018-2823-0.
PubMed 30119697
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Training on Physical Activity Levels and Sedentary Behavior in Subjects Post-stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02798237
- Acronym / sponsor ID
- CAAE:51454115.6.0000.5149
- Conditions
- Stroke
- Keywords
- exercise, walking, health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 14 Jun 2016 (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.
Physical activity level is an important determinant of quality of life in persons post-stroke. There is a lack of knowledge regarding the effects of aerobic training on physical activity levels in subjects post-stroke. Therefore, the primary objective will be to investigate the effects of aerobic treadmill training on physical activity levels and sedentary behavior in subjects post-stroke. The secondary aim will be to investigate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation.
A randomized controlled trial with blinded assessment will assign eligible participants to either: 1) aerobic treadmill training (experimental group, at 60-80% of heart rate reserve), or 2) overground walking (control group, below 40% of heart rate reserve). Both groups will receive 40-minute training sessions three times/week over 12-weeks, in groups of 2-4 participants, by a trained physiotherapist. Primary outcomes: physical activity levels and sedentary behavior (Multisensor SenseWear Mini® and Human Activity Profile). Secondary outcomes: cardiorespiratory fitness (peak oxygen uptake (VO2peak) and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the trainings will be analyzed from the collected data and intention-to-treat analysis. Between-groups differences will be measured by two-way ANOVA with repeated measures considering the baseline, post-training, and a 4-week follow-up.
The results of this trial will likely provide valuable new information about the effects of aerobic treadmill training in improving physical activity levels and sedentary behavior, through changes in cardiorespiratory fitness, for individuals following stroke.
Detailed description
The sample size has been calculated considering the physical activity levels measured by the Human Activity Profile (HAP). The effect size has been derived from the study of Teixeira-Salmela et al. 1999, who performed aerobic training in addition to lower limbs resistance training, and home exercises with subjects with chronic stroke. The experimental group (n=6) showed an increase on HAP on average of 20±6.1 points after the intervention, and the control group (n=7) had an average reduction of 1.86±0.19 points. Considering a significance level of 5% and a desired power of 80%, 9 participants per group was found, or 18 participants in total. Assuming an expected dropout rate of 20%, a target of 22 participants in total was set (11 participants per group).
Statistical analyses: A code will be given to each participant. Two independent examiners, blinded to the group allocation, will perform data entry, and verify missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. An independent examiner, blinded to the group allocation, will perform the statistical analysis by SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be performed for all outcome variables. Baseline variables will be compared between groups using independent Student's t-tests, to investigate differences among the groups regarding the clinical-demographical characteristics. If differences between the groups at baseline exist, analysis of covariance will be used to eliminate the influence of extraneous factors. The effects of the interventions will be analyzed from the collected data and the intention-to-treat analysis. Data from the last available assessment will be considered as the values of missed sessions. Between-groups differences will be measured with two-way ANOVA with repeated measures considering the baseline, post-training, and follow-up measures. Level of significance will be set at 0.05 and adjusted for multiple comparisons. Normality and equality of variance will also be analyzed to ensure correct use of parametric data. Study results will be spread regardless of the magnitude and direction of the effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic treadmill training | Experimental | Other: Aerobic treadmill trainingParticipants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized. Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill. |
| Control (overground walking) | Sham comparator | Other: Control (overground walking)Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 20years of age;
- diagnosis of stroke (>6months);
- sedentary or insufficiently active;
- have a writing medical permission to participate in the training program.
Key exclusion criteria (3 listed)
- cognitive impairment (Mini-Mental Status Examination score: illiterate 13 points; elementary and middle school 18 points; and high-school 26 points; or inability to respond to verbal command);
- inability to walk independently for at least 10 minutes, with or without walking devices;
- pain or other disorders precluding their participation.
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 |
|---|---|---|
| Aerobic treadmill trainingParticipants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized. Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill. | Other | Aerobic treadmill training |
| Control (overground walking)Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the exercise, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program | Other | Control (overground walking) |
Primary outcome
Change from baseline in Physical activity levels - multisensor monitor
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Physical activity levels will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
Change from baseline in Physical activity levels - Human Activity Profile
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Physical activity levels will be assessed by Human Activity Profile
Change from baseline in sedentary behavior - multisensor monitor
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Sedentary behavior will be assessed by a multisensor monitor (SenseWear®, BodyMedia, Pittsburgh, USA).
7 secondary outcomes
Change from baseline in Cardiorespiratory fitness - cardiopulmonary exercise test
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - six minute walk test
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Endurance - shuttle walk test
Time frame: At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Depression - Patient Health Questionnaire (PHQ-2 and PHQ-9)
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Mobility - gait speed
Time frame: At baseline,12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Quality of life - Stroke specific quality of life
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
Change from baseline in Participation - Stroke impact scale
Time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up
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 15 May 2019.
- Background: PubMed 23428993Pang MY, Charlesworth SA, Lau RW, Chung RC. Using aerobic exercise to improve health outcomes and quality of life in stroke: evidence-based exercise prescription recommendations. Cerebrovasc Dis. 2013;35(1):7-22. doi: 10.1159/000346075. Epub 2013 Feb 14.
- Background: PubMed 24846875Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.
- Derived from this study: PubMed 34184251Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.
- Derived from this study: PubMed 30119697Aguiar LT, Nadeau S, Britto RR, Teixeira-Salmela LF, Martins JC, Faria CDCM. Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial. Trials. 2018 Aug 17;19(1):446. doi: 10.1186/s13063-018-2823-0.
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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.
Christina Faria, Ph.D. principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aerobic treadmill training in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 3 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 15 May 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in Physical activity levels - multisensor monitor (time frame: At baseline, 12 weeks post-intervention, and at 4-week follow-up). The study lists 3 primary outcomes in all. 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 NCT02798237, which also lists 4 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 15 May 2019.