Bariatric Surgery CandidateOCAPASNCT04478331
Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery
A study testing Technology-based physical activity interventions in people with Bariatric Surgery Candidate, run by Pr Fabienne d'Arripe-Longueville at 1 site in France.
Trial summary
Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Technology-based physical activity interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2020to Apr 2022
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Undergone bariatric surgery at a tertial referral center for bariatric surgery (Nice University Hospital, France) 3 to 6 months ago
- Respect with the national recommendations (e.g., BMI ≥ 40kg/m² or ≥ 35kg/m² with at least one co-morbidity among blood hypertension, type 2 diabetes, invalidating arthritis, and sleep apnea syndrome; and no physical disability to practice PA)
- Having a smartphone compatible with the proposed technologies.
Who cannot join
- Serious adverse events
- Withdrawal of informed consent or violation of the protocol
Trial locations and contacts
1 site in 1 country.
Fabienne d'Arripe-Longueville, Pr contact
About this study
Official title: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study
Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.
The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.
Read more
One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.
This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Technology-based physical activity interventions
- Keywords
- obesity, physical activity, information and communication technology, engagement, active lifestyle, technology-based program, eHealth, videoconferencing, mobile application
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based physical activity interventionsBehavioural
The technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | The Control group will receive the usual care. In the physical activity (PA) field, this includes two individual motivational interviews with a PA professional, and a group workshop during the first year after BS. PA recommendations will be explained to each participant, and their achievement will be encouraged and supported during these sessions. No face-to-face PA sessions will be offered as part of the usual care. |
| ACTI-VISIO | Experimental | The two PA sessions per week will be delivered via videoconferencing (developed by Mooven™). The PA program consists in tailored adapted PA sessions led by a professional specialized in adapted PA. These sessions were specifically designed to be appropriate for the population and were developed in collaboration with the authors to ensure standardization of the recommended volume of PA. The PA sessions will be given live, individually at the beginning and then in groups of four women. During sessions, the professional and the participants will interact simultaneously, and the execution of the exercises will be monitored and adapted live by the professional. To ensure the safety of the PA, a rating of perceived exertion will be requested after each session on a 10-point scale. If the RPE exceed 7, the professional specialized in adapted PA will adjust the training load. In addition to the exercises, the sessions will also include advice and tips for reaching the recommended PA level. Receives: Behavioral: Technology-based physical activity interventions |
| ACTI-MOBIL | Experimental | The PA sessions will be delivered by an eHealth platform (developed by BePatient™) associated with an activity bracelet. The researchers enrich PA content on the platform and ensure standardization of the recommended volume of PA. The platform consists of tips for reaching the PA level, PA questionnaires, PA feedback measured by the activity bracelet, and a video demonstration of PA sessions performed by a peer. The PA sessions are automatically broadcasted twice a week for 12 weeks. To ensure the safety of the PA, the sessions were designed to be appropriate for this population and the RPE will be measured after each session on a 10-point scale. If the RPE exceeds 7 for 3 consecutive sessions, the training load will be adjusted. The platform will also include a variety of content, including dietary tips, obesity-related facts, information about surgery, and frequently asked questions. Receives: Behavioral: Technology-based physical activity interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula
We will aggregate the following primary outcome measures into the Capodaglio (2013) formula: 894.2177 - (2.0700 x age(years)) - (51.4489 x 1) - 5.1663 x BMI (kg/m²) to obtain the theoretical distance, and we will calculate the percentage achievement of this theoretical distance: ((distance traveled(meters) - theoretical distance(meters)) / theoretical distance(meters))x100.
Higher percentage of achievement reflecting higher functional capacity.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of distance traveled during a six-minute walk test (6MWT)
Distance traveled during a six-minute walk test (6MWT) will be expressed in meters
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body mass
Kilograms
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Height
Meters
Measured: Baseline (T0)
Date of birth
The date of birth will be requested once (pre-bariatric surgery) and will be used to calculate the age in years at the different periods needed to calculate the theoretical 6MWT distance
Measured: Baseline (T0)
Secondary outcomes (9)
Change of subjective physical activity level
Global Physical Activity Questionnaire validated in the French language (Rivière et al., 2018). This scale comprises 16 items to assess the frequency and duration of PA during work, transportation, leisure time, and time spent sitting in a typical week. The items are used to calculate the energy expenditure score in metabolic equivalent tasks (METs), where 150 minutes per week of moderate to vigorous PA corresponds to 600 MET-min/week.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of objective physical activity level
Axivity AX3 triaxial accelerometer worn on the wrist during 7-day period. The sensor will be set to begin recording at midnight the day after the appointment over a 7-day period at 100 Hz with a dynamic range of ±8g. The AX3 data will be downloaded, resampled, calibrated and analyzed using open-source AX3 OmGui software (OmGui Version 1.0.0.43, Open Movement, Newcastle University, UK).
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of stage of change for physical activity
Stage of Change for physical activity will be measured using the French version of the Stages of Change questionnaire (Romain et al., 2012). Regular PA and exercise are defined as "at least 30 minutes per session, at least 5 days per week of moderate to vigorous PA." This questionnaire includes five items with a "yes" or "no" answer, transformed by an algorithm to attribute a score to each participant according to her stage (precontemplation=1, contemplation=2, preparation=3, action=4 or maintenance stage=5).
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of energetic consumption measured during the 6MWT
The physiological variables will be measured during the 6MWT: oxygen uptake, minute ventilation, carbon dioxide output, respiratory exchange ratio, and heart rate, using the Cosmed K5 system (Cosmed K5, Rome, Italy), which consists of a mask and a portable unit. A decrease in energetic consumption for the same distance travelled during the 6MWT reflecting a better adaptation to exercise.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of muscle strength
The maximal isometric knee extensor muscles' strength of the left and right lower limb will be measured with the MicroFET2 (Hoggan Scientific, LLC, Salt Lake City, UT, USA). Women will be seated in a chair with the assessed limb placed at a knee angle of 90° (with full knee extension corresponding to 180°). They will be asked to push as hard as possible for 5 seconds against the dynamometer held by a strap attached to the chair. The highest value in Newton (N) of three measurements will be recorded, and the average of both limbs results will be used for analysis.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of quality of life in 5 dimensions
Quality of life will be assessed with the French version of the EuroQoL-5-Dimensions (EQ-5D, Jannssen et al., 2013). The EQ-5D comprises five items measuring quality of life along five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants have five response options ranging from "no problems" to "unable." Lower scores indicating better quality of life.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of quality of life in visual analog scale
Quality of life will be assessed with the French version of the EuroQoL-visual analog scale (EQ-VAS, Jannssen et al., 2013). The EQ-VAS has a single item for which the women will be asked to rate their current health on a scale from 0: "worst imaginable" to 100: "best imaginable." Higher scores indicating better quality of life
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body mass index
Height (meters) and body mass (kilograms) will be measured by medical staff and used to calculate the BMI (kg/m²).
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body composition
Body composition will be measured by bioimpedance using the Biody XpertZM (Aminogram, France): muscle mass (kg), fat mass (kg), and bone mineral content (kg). For analyses these measures will be converted to percentages.
Measured: Baseline (T0), 3 months (T3), and 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start26 Oct 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr Fabienne d'Arripe-Longueville
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Association Azur Sport Santé, Nice, France
- Responsible party
- Sponsor-investigator, Pr Fabienne d'Arripe-Longueville, Universite Cote d'Azur
- Investigators
- Fabienne d'Arripe-Longueville, Pr, Study director, Université Côte d'Azur, Nice, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478331
- Sponsor's protocol ID
- IDRCB: 2020.A00172-37
- Other IDs
- ANR-15-IDEX-01
- Acronym
- OCAPAS
- Status last verified
- Nov 2020
- First submitted
- 10 Jul 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayotte M, Iannelli A, Negre V, Pradier C, Therouanne P, Fuch A, Diagana O, Garbarino JM, Vuillemin A, Colson SS, Chevalier N, d'Arripe-Longueville F. Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. BMJ Open. 2021 Jul 30;11(7):e046184. doi: 10.1136/bmjopen-2020-046184.
PubMed 34330855
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study
- ClinicalTrials.gov ID
- NCT04478331
- Acronym / sponsor ID
- OCAPAS / IDRCB: 2020.A00172-37
- Conditions
- Bariatric Surgery Candidate
- Keywords
- obesity, physical activity, information and communication technology, engagement, active lifestyle, technology-based program, eHealth, videoconferencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pr Fabienne d'Arripe-LonguevilleUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Association Azur Sport Santé, Nice, France
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 20 Jul 2020 (actual)
- 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.
Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.
The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.
One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.
This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –The Control group will receive the usual care. In the physical activity (PA) field, this includes two individual motivational interviews with a PA professional, and a group workshop during the first year after BS. PA recommendations will be explained to each participant, and their achievement will be encouraged and supported during these sessions. No face-to-face PA sessions will be offered as part of the usual care. |
| ACTI-VISIO | Experimental | Behavioral: Technology-based physical activity interventionsThe two PA sessions per week will be delivered via videoconferencing (developed by Mooven™). The PA program consists in tailored adapted PA sessions led by a professional specialized in adapted PA. These sessions were specifically designed to be appropriate for the population and were developed in collaboration with the authors to ensure standardization of the recommended volume of PA. The PA sessions will be given live, individually at the beginning and then in groups of four women. During sessions, the professional and the participants will interact simultaneously, and the execution of the exercises will be monitored and adapted live by the professional. To ensure the safety of the PA, a rating of perceived exertion will be requested after each session on a 10-point scale. If the RPE exceed 7, the professional specialized in adapted PA will adjust the training load. In addition to the exercises, the sessions will also include advice and tips for reaching the recommended PA level. |
| ACTI-MOBIL | Experimental | Behavioral: Technology-based physical activity interventionsThe PA sessions will be delivered by an eHealth platform (developed by BePatient™) associated with an activity bracelet. The researchers enrich PA content on the platform and ensure standardization of the recommended volume of PA. The platform consists of tips for reaching the PA level, PA questionnaires, PA feedback measured by the activity bracelet, and a video demonstration of PA sessions performed by a peer. The PA sessions are automatically broadcasted twice a week for 12 weeks. To ensure the safety of the PA, the sessions were designed to be appropriate for this population and the RPE will be measured after each session on a 10-point scale. If the RPE exceeds 7 for 3 consecutive sessions, the training load will be adjusted. The platform will also include a variety of content, including dietary tips, obesity-related facts, information about surgery, and frequently asked questions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Undergone bariatric surgery at a tertial referral center for bariatric surgery (Nice University Hospital, France) 3 to 6 months ago
- Respect with the national recommendations (e.g., BMI ≥ 40kg/m² or ≥ 35kg/m² with at least one co-morbidity among blood hypertension, type 2 diabetes, invalidating arthritis, and sleep apnea syndrome; and no physical disability to practice PA)
- Having a smartphone compatible with the proposed technologies.
Key exclusion criteria (2 listed)
- Serious adverse events
- Withdrawal of informed consent or violation of the protocol
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 |
|---|---|---|
| Technology-based physical activity interventionsThe technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations. | Behavioural | ACTI-MOBIL, ACTI-VISIO |
Primary outcome
Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
We will aggregate the following primary outcome measures into the Capodaglio (2013) formula: 894.2177 - (2.0700 x age(years)) - (51.4489 x 1) - 5.1663 x BMI (kg/m²) to obtain the theoretical distance, and we will calculate the percentage achievement of this theoretical distance: ((distance traveled(meters) - theoretical distance(meters)) / theoretical distance(meters))x100. Higher percentage of achievement reflecting higher functional capacity.
Change of distance traveled during a six-minute walk test (6MWT)
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Distance traveled during a six-minute walk test (6MWT) will be expressed in meters
Change of body mass
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Kilograms
Height
Time frame: Baseline (T0)
Meters
Date of birth
Time frame: Baseline (T0)
The date of birth will be requested once (pre-bariatric surgery) and will be used to calculate the age in years at the different periods needed to calculate the theoretical 6MWT distance
9 secondary outcomes
Change of subjective physical activity level
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of objective physical activity level
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of stage of change for physical activity
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of energetic consumption measured during the 6MWT
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of muscle strength
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of quality of life in 5 dimensions
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of quality of life in visual analog scale
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body mass index
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body composition
Time frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 34330855Hayotte M, Iannelli A, Negre V, Pradier C, Therouanne P, Fuch A, Diagana O, Garbarino JM, Vuillemin A, Colson SS, Chevalier N, d'Arripe-Longueville F. Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. BMJ Open. 2021 Jul 30;11(7):e046184. doi: 10.1136/bmjopen-2020-046184.
- Individual participant dataSharing planned: No
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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.
Fabienne d'Arripe-Longueville, Pr contact
Fabienne d'Arripe-Longueville, Pr study director
Université Côte d'Azur, Nice, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based physical activity interventions in people with Bariatric Surgery Candidate, run by Pr Fabienne d'Arripe-Longueville at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. 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 France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne d'Arripe-Longueville, Pr (762485953 ext. +33, fabienne.d-arripe-longueville@univ-cotedazur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula (time frame: Baseline (T0), 3 months (T3), and 6 months (T6)). The study lists 5 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 NCT04478331, which also lists 1 linked publication.
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 30 Nov 2020.