Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
February 13, 2023 updated by: Siobhan M Phillips, Northwestern University
Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology.
MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity.
This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden.
The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
280
Phase
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosed with Stage I-III breast cancer within the last 5 years
- Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- English speaking
- Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- Own a smartphone
- Have access to a computer with Internet
- Participants may be using adjuvant endocrine therapies.
- Willing to be waitlisted for future wave if current wave reaches capacity
Exclusion Criteria:
-Women will be excluded if they report any of the following:
- Respiratory, joint or cardiovascular problems precluding physical activity
- Metastatic disease
- Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
- A prior cardiovascular event (i.e. stroke, myocardial infarction)
- Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Number of Arms
32
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Experimental Condition #1
core, support calls
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
|
|
Experimental: Experimental Condition #2
core, support calls, app+
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
|
|
Experimental: Experimental Condition #3
core, support calls, buddy
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|
Experimental: Experimental Condition #4
core, support calls, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #5
core, support calls, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #6
core, app+
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
|
|
Experimental: Experimental Condition #7
core, app+, buddy
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|
Experimental: Experimental Condition #8
core, app+, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #9
core, app+, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #10
core, buddy
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|
Experimental: Experimental Condition #11
core, buddy, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #12
core, buddy, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #13
core, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #14
core, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #15
core, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #16
core, support calls, app+, buddy
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|
Experimental: Experimental Condition #17
core, support calls, app+, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #18
core, support calls, app+, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #19
core, support calls, buddy, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #20
core, support calls, buddy, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #21
core, support calls, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #22
core, app+, buddy, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #23
core, app+, buddy, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #24
core, support calls, buddy, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #25
core, buddy, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #26
core, app+, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #27
core, support calls, app+, buddy, online gym
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
|
|
Experimental: Experimental Condition #28
core, support calls, app+, buddy, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #29
core, support calls, app+, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #30
core
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
|
|
Experimental: Experimental Condition #31
core, app+, buddy, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive motivational app notifications
|
|
Experimental: Experimental Condition #32
core, support calls, app+, buddy, online gym, app notifications
|
The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Participants will receive 6 bi-weekly phone calls from study staff.
Participants will receive "deluxe" version of smartphone app with additional features.
Participants will choose a buddy to receive a Fitbit and support them during the intervention.
Participants will receive access to online exercise videos.
Participants will receive motivational app notifications
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to a 12 Week Technology Supported Physical Activity Intervention
Time Frame: 12 weeks
|
Adherence during the 12 week intervention will be monitored continuously using study app.
This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
|
12 weeks
|
|
Participant Retention
Time Frame: 12 weeks
|
Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100].
|
12 weeks
|
|
Intervention Reach
Time Frame: Baseline
|
Percentage of individuals randomized of those who were sent a study screening survey
|
Baseline
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
Time Frame: Change from baseline to 12 weeks
|
Physical activity will be measured at baseline and at 12 weeks.
The ActiGraph accelerometer will be used.
At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming.
Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
|
Change from baseline to 12 weeks
|
|
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
Time Frame: Change from baseline to 24 weeks
|
Physical activity will be measured at baseline and at 24 weeks.
The ActiGraph accelerometer will be used.
At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming.
Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
|
Change from baseline to 24 weeks
|
|
Change in Fatigue From Before to After a 12-Week Intervention
Time Frame: Change from baseline to 12 weeks
|
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure.
T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
|
Change from baseline to 12 weeks
|
|
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
Time Frame: Change from baseline to 24 weeks
|
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure.
T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
|
Change from baseline to 24 weeks
|
|
Change in Physical Function From Before to After a 12-Week Intervention
Time Frame: Change from baseline to 12 weeks
|
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure.
T-scores range from 32.7 to 62.7.
Higher scores indicate better physical functioning.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
|
Change from baseline to 12 weeks
|
|
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
Time Frame: Change from baseline to 24 weeks
|
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure.
T-scores range from 32.7 to 62.7.
Higher scores indicate better physical functioning.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
|
Change from baseline to 24 weeks
|
|
Change in Depression From Before to After a 12-Week Intervention
Time Frame: Change from baseline to 12 weeks
|
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure.
T-scores range from 38.2 to 81.3.
Higher scores indicate more depression.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
|
Change from baseline to 12 weeks
|
|
Change in Depression From Pre-Intervention to 24-week Follow-up
Time Frame: Change from baseline to 24 weeks
|
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure.
T-scores range from 38.2 to 81.3.
Higher scores indicate more depression.
T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
|
Change from baseline to 24 weeks
|
|
Adherence to During the Full 24-Week Study Period
Time Frame: 24 weeks
|
Adherence during the 24-week study period will be monitored continuously using study app.
This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
|
24 weeks
|
|
Participant Retention at 24 Week Follow-up
Time Frame: 24 weeks
|
Percentage of participants retained at 24 weeks of those randomized
|
24 weeks
|
|
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
|
Change from baseline to 12 weeks
|
|
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
|
Change from baseline to 24 weeks
|
|
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
|
Change from baseline to 12 weeks
|
|
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Higher IL-10 may have protective effects.
|
Change from baseline to 24 weeks
|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Lower values are better.
|
Change from baseline to 12 weeks
|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
TLower values are better.
|
Change from baseline to 24 weeks
|
|
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA.
Lower values are better.
|
Change from baseline to 12 weeks
|
|
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA.
Lower values are better.
|
Change from baseline to 24 weeks
|
|
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
|
Change from baseline to 12 weeks
|
|
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Lower values are better.
|
Change from baseline to 24 weeks
|
|
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
|
Change from baseline to 12 weeks
|
|
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
Time Frame: Change from baseline to 24 weeks
|
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
|
Change from baseline to 24 weeks
|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
Time Frame: Change from baseline to 12 weeks
|
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
|
Change from baseline to 12 weeks
|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
Time Frame: Change from baseline to 24 weeks
|
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
|
Change from baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
April 24, 2017
Primary Completion (Actual)
Primary Completion
June 17, 2019
Study Completion (Actual)
Study Completion
June 17, 2019
Study Registration Dates
First Submitted
First Submitted
April 18, 2017
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
First Posted
April 27, 2017
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
March 10, 2023
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- K07CA196840 (U.S. NIH Grant/Contract)
- R21CA219028-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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