Physical Inactivity Clinical Trial
— MKS+Official title:
Expansion and Spread of Makoyoh'Sokoi, the Wolf Trail, a Community Led, Culturally Relevant, Physical Activity-based, Holistic Wellness Program for Indigenous Women; a Self-control, Non- Randomized, Intervention Trial in Seven Communities (10 Sites) in Alberta and Saskatchewan
NCT number | NCT05362435 |
Other study ID # | 21-1305 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 22, 2021 |
Est. completion date | June 2024 |
During the MKS+ program participants complete health education modules that expose them to health information, a substantial portion of which relate to healthy nutrition and prevention, and on occasion to local healthcare providers. The goal is to increase activation and the ability to manage one's own health. In each community, the Community Organisational Leads will support the Facilitators to establish a comprehensive resource list of healthcare professionals. Additionally, through exposure to local Indigenous Knowledge Keepers and Elders, along with cultural and spiritual elements, the participants will know how to access activities that may further support their wellness. The MKS+ program shows promise as a community-based model for supporting Indigenous women to improve their health. It is grounded in community; increases self-efficacy through the opportunity to learn, practice, and share in manageable increments; and increases health literacy through program contents and coordinating healthcare knowledge exchange with other healthcare providers from the community. By connecting to aspects of Indigenous culture, participants can be affirmed in their identities and learn more about how connecting to culture may be protective of their health through a restored sense of self-worth, sharing, and community support. At the individual participant level the investigators anticipate the participants will a) improve their fitness, body composition and cardiometabolic health, b) improve their quality of life and mental health, c) develop strong support networks, d) be exposed to cultural elements in their community that the participants were not previously aware of that may lead to engagement, better understanding and easier access to their community resources, e) learn about healthy diet composition - shopping, cooking, and meal planning which will lead to improved nutrition, and f) understand the importance of health screening and smoking cessation. The investigators' earlier pilot work established these outcomes and the investigators are hopeful because this project will support an extended program that will include an additional 12 weeks of less intense, follow-up programming, that the investigators will also find that these elements are sustained at one-year post-programming. In previous grants, the investigators have never had the opportunity to extend the program in this way.
Status | Recruiting |
Enrollment | 1250 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Indigenous women from the following participating communities in rural and urban Alberta and Saskatchewan: Calgary (3 communities), Edmonton, Onion Lake Cree Nation, Waterhen Lake First Nation, Flying Dust First Nation, Ministikwan Lake Cree Nation, and Piikani Nation. - Indigenous women may identify as Métis, First Nations or Inuit, living both on- and off-reserve - Women, defined as gender female, and may include cis-female, binary, trans- females, queer and two-spirited individuals. - 18 years old and older. Exclusion Criteria: - Pregnancy and breastfeeding. |
Country | Name | City | State |
---|---|---|---|
Canada | Miskanawah | Calgary | Alberta |
Canada | Edmonton | Edmonton | Alberta |
Canada | Flying Dust First Nation | Flying Dust First Nation | Saskatchewan |
Canada | Ministikwan Lake Cree Nation | Ministikwan Lake | Saskatchewan |
Canada | Onion Lake Health Centre | Onion Lake | Saskatchewan |
Canada | Piikani First Nation | Piikani Nation | Alberta |
Canada | Waterhen Lake First Nation | Waterhen Lake | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Public Health Agency of Canada (PHAC) |
Canada,
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Devlin N, Parkin D, Janssen B. Methods for Analysing and Reporting EQ-5D Data [Internet]. Cham (CH): Springer; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK565678/ — View Citation
Forde C. Exercise Prescription for the Prevention and Treatment of Disease. Scoring the International Physical Activity Questionnaire (IPAQ). Trinity College Dublin, The University of Dublin. 2016. https://ugc.futurelearn.com/uploads/files/bc/c5/bcc53b14-ec1e-4d90-88e3-1568682f32ae/IPAQ_PDF.pdf
Frehlich L, Blackstaffe A, McCormack GR. Test-Retest Reliability and Walk Score(R) Neighbourhood Walkability Comparison of an Online Perceived Neighbourhood-Specific Adaptation of the International Physical Activity Questionnaire (IPAQ). Int J Environ Res Public Health. 2019 May 30;16(11):1917. doi: 10.3390/ijerph16111917. — View Citation
Halls, S.B. Body Fat Percentage: Find Out Yours. Halls.md. Body fat percentage formula from body mass index (halls.md). 2019.
Kading ML, Hautala DS, Palombi LC, Aronson BD, Smith RC, Walls ML. Flourishing: American Indian Positive Mental Health. Soc Ment Health. 2015 Nov;5(3):203-217. doi: 10.1177/2156869315570480. Epub 2015 Feb 2. — View Citation
Radandt NE, Corbridge T, Johnson DB, Kim AS, Scott JM, Coldwell SE. Validation of a Two-Item Food Security Screening Tool in a Dental Setting. J Dent Child (Chic). 2018 Sep 15;85(3):114-119. — View Citation
Rao DP, Dai S, Lagace C, Krewski D. Metabolic syndrome and chronic disease. Chronic Dis Inj Can. 2014 Feb;34(1):36-45. English, French. — View Citation
Robinson CA, Agarwal G, Nerenberg K. Validating the CANRISK prognostic model for assessing diabetes risk in Canada's multi-ethnic population. Chronic Dis Inj Can. 2011 Dec;32(1):19-31. — View Citation
Sallis JF, Bowles HR, Bauman A, Ainsworth BE, Bull FC, Craig CL, Sjostrom M, De Bourdeaudhuij I, Lefevre J, Matsudo V, Matsudo S, Macfarlane DJ, Gomez LF, Inoue S, Murase N, Volbekiene V, McLean G, Carr H, Heggebo LK, Tomten H, Bergman P. Neighborhood environments and physical activity among adults in 11 countries. Am J Prev Med. 2009 Jun;36(6):484-90. doi: 10.1016/j.amepre.2009.01.031. — View Citation
Wicklum, S., Sampson, M., Henderson, R., Wiart, S., Perez, G., McGuire, A., Cameron, E., Willis, E., Crowshoe, L., McBrien, K. Results of a culturally relevant, physical activity-based wellness program for urban indigenous women in Alberta, Canada. International Journal of Indigenous Health. 2019; 14(2), 169-204. https://doi.org/10.32799/ijih.v14i2.31890.
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Activation | Participants' engagement in their own healthcare as measured by the Patient Activation Measure (PAM™). Patient activation implies a "willingness and ability to take independent actions to manage their health and care". The PAM™ score has been used to assess effectiveness of diabetes prevention programming in Indigenous populations. It is a well-validated tool to assess effectiveness of interventions for many chronic diseases and small increases in PAM score have been shown to correlate to reduced healthcare costs and improved health status. PAM™ levels are defined as follows: Level 1 <47, Level 2 47.1 - 55.1, Level 3 55.2 - 67.0, Level 4 >67.1. To assess changes in PAM™ scores over time the analysis will focus on score changes within each level. Previous studies show that most change occurs within the lowest levels of activation (Levels 1 and 2), and patients with lower activation also tend to have higher utilization and costs. So, both the PAM™ score and PAM™. | PAM scores will be collected immediately pre-program (Week 1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Primary | Physical Activity - Change in Step Counts | The investigators use pedometers to track weekly step counts. Pedometers were chosen to assess physical activity because they were successfully used in the previous MKS programs, provide immediate motivational feedback to participants, and are cost effective and validated. Pedometer use will be evaluated the following ways: 1) # who are compliant with bringing their pedometers weekly and # who have kept track of their total steps, 2) average % change in weekly step count between Time 2, Time 3 and Time 4 (or last class attended) (presented as mean +/- SD, median and range). 3) % reporting continued use of their pedometer at Time 5. 4) | Change in step-counts will be studies between the start of the program (Week 1; Time 1), the end of the live program (Week 12; Time 2), the end of the follow-up period (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Primary | Physical Activity - Change in International Physical Activity Questionnaire Results | The Neighbourhood - International Physical Activity Questionnaire (N-IPAQ) will be completed. The N-IPAQ is a reliable, validated, and easy to administer questionnaire that measures neighbourhood-based physical activity There are two forms of output from scoring the N-IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. For continuous variable such as weekly step counts, MET minutes, the mean (SD) will be shown and statistical methods including paired t-test and repeated measurement ANOVA, linear (mixed effect) regression methods will be used to discover whether the program participants will have more step counts over time. For categorical data such as the level of physical activity on the N- IPAQ, the frequency distribution will be presented and Chi-square test and generalized | The N-IPAQ will be completed immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Primary | Participant quality of life, sense of belonging and mental health - Main | Change in Mental Health Continuum-Short Form (MHC-SF) category uses three categories (languishing, moderate, flourishing) coded as 0, 1, and 2. % of participants in each category at T1, T4 and T5 will be reported along with change in category over time. Statistical method for example, two proportion test, and Chi-square tests will be used to identify whether the programming will improve the participants' well-being in three components: emotional, social, and psychological. In addition, the correlation analysis between this MHC-SF measures with other outcomes will help to reveal whether this outcome is correlated to variables such as the 12-item Short Form Survey (SF-12), Canadian Health Measures Survey GEN_18, Patient Activation Measure (PAM) and BMI (kg/m2) etc. Generalized linear mixed model will also be used for the repeated measurements collected pre and post program considering other potential factors or outcomes as adjusting covariates in the model. | Responses will be collected immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Primary | Change in participant quality of life, sense of belonging and mental health - Main | The Medicine Wheel is a visual tool to reflect the holistic view of balance in one's life. The four quadrants are comprised of Physical, Emotional, Mental, and Spiritual. Qualitative methods will be used to explore how the program has impacted where participants are with respect to the Medicine Wheel at the end of the program, using a Medicine Wheel Likert Scale.
A peer-researcher will be identified during the second month of each program. The peer-researcher will be trained in the photo/video-voice method. Peer-researchers will meet with participants and educate the participant on how to create a photovoice/video to answer the question. The Medicine Wheel Likert Scale is incorporated into this reflective process. The peer-researcher will support them with editing and compile the exercises. |
Qualitative research will happen after the full program (Week 18 or 24; Time 3) and one year after the full program (Week 70 or 76; Time 4) to determine change in quality of life. | |
Secondary | Participant cardiometabolic health - Metabolic Syndrome | Blood pressure, waist circumference, biochemistries, and demographic data will be collected to determine prevalence of Metabolic Syndrome (MetS) and whether this changes throughout the program.
The revised National Cholesterol Education Program Adult Treatment Panel III criteria, state that metabolic syndrome is present if three or more of the following criteria are met: abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women)- numbers vary based on ethnicity; elevated plasma triglyceride level (= 1.7 mmol/L); decreased high-density lipoprotein (HDL) cholesterol level (< 1.03 mmol/L for men and < 1.30 mmol/L for women); elevated blood pressure (= 130/85 mm Hg); or elevated fasting glucose level (= 6.1 mmol/L). Report % with Met Syndrome initially for whom health improved such that they did not meet criteria at Time 4 (immediately post-program) and Time 5 (52 weeks post the end of the program). |
Presence of metabolic syndrome will be assessed immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant cardiometabolic health - medication usage | As part of the investigators' understanding of participant cardiometabolic health, we will collect information on participant medication usage; decreasing or initiating medications for diabetes or cardiovascular risk reduction
The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables. |
Medication use will be evaluated immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant cardiometabolic health - resting heart rate | Resting heart rate will be evaluated as an indicator of cardiometabolic health. A lower resting heart rate at subsequent measures will be considered a sign of improved fitness. Resting heart rate is also required as part of the calculation for the 1-mile walk test.
The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables. |
Resting heart rate will be evaluated immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant cardiometabolic health - smoking status | Information on smoking status, and changes to smoking status throughout the program, will be collected through a questionnaire. Reduced smoking frequency and smoking cessation will be viewed as a positive health change.
The descriptive statistics will be presented with mean (SD) and frequency for categorical data. The changes in those measures be analyzed by using a variety of methods such as t-test, repeated ANOVA and mixed effect model for continuous data and generalized linear mixed effect model regression for any categorized variables. |
Information on smoking status will be collected immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant cardiometabolic health - CANRISK | Canadian Diabetes Risk Questionnaire (CANRISK) score
Composed of 12 questions, CANRISK collects information on the following risk factors: age group, sex, ethnicity, education, BMI (kg/m2), waist circumference, daily physical activity, daily fruit and vegetable consumption, history of high blood pressure, blood sugar, family history of diabetes, smoking status and macrosomia. The CANRISK Survey evaluates diabetes risk as "low risk" (a score lower than 21), "moderate risk" (a score of 21-32), and "high risk" (a score of 33 and over). Report % of participants who did not have known Type-2 Diabetes Mellitus, who increased, decreased or experienced no change in CANRISK score. |
CANRISK scores will be calculated immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant anthropometrics | Body-composition measures such as weight, height, and waist circumference will be collected, and then the investigators will calculate BMI (kg/m2), body adiposity index (BAI), and body fat percentage by using: body fat percentage= (1.20 X BMI) + 0.23 X age -5.4 (females with age >15). The data will be summarized with mean (SD) and median (IQR) for each time point at Time 1 (3 months pre-program) to Time 5 (1 year after the end of the program). The changes over time will also be evaluated by using longitudinal modeling methods (such as mixed effect model) as well as repeated measure ANOVA. The weight scale used uses impedance methods to calculate a % body fat but is limited at higher percentages. The investigators will compare percent body fat using both methods. Categorized BMI or body fat percentage based on WHO's method will be also presented with frequency and generalized linear mixed effect model will be applied to evaluate the changes over time from Time 1 to Time 5. | Anthropometric measures will be completed immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Fitness - Grip Strength | Grip strength is found to correlate to longevity and fitness, and as participants are exposed to strength-based trainings, the investigators will use handgrip dynamometer to track the changes in strength of participants. This data will be presented with mean (SD) in different age groups and the % change from the previous time points. Linear regression will be used to evaluate whether significant changes in grip strength are observed among participants throughout and after the program the program. | Grip strength will be completed immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Fitness - 1-mile walk test | For 1-Mile Walk Test, the data of total minutes and VO2_MAX will be calculated and presented with mean -/+ SD and the categorized data based on VO2_max are also be presented with their frequency distribution in different age groups. The changes in the measures will be evaluated based on repeated ANOVA methods and linear regression by adjusting for potential factors such as age, smoking status, BMI and so on. To perform the 1-mile walking test: 1) Warm up for 5-10 minutes. 2) Start your stopwatch and start walking as fast as you can. 3) At the end of 1 mile, record your time in decimals. 4) Take your heart rate immediately. 5) Calculate VO2_max with provided formula (VO2 max = 132.853 - (0.0769 x your weight in pounds) - (0.3877 x your age) + (6.315 if you are male or 0 if you are female) - (3.2649 x your walking time) - (0.1565 x your heart rate at the end of the test)) 6) Determine the different levels based on the provided table. | The 1-mile walk test will be completed immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant quality of life, sense of belonging and mental health | Improvements in quality of life will be assessed using the EQ-5D- 5L™. The investigators are going to collect three measure from EQ-5D-5L: EQ5D profile, EQ5D Vas, EQ5D measures. In addition to presenting descriptive statistics including mean (SD) and frequencies in each level for all those measures at each time points and use t-test to evaluate the changes, longitudinal analysis will be conducted to check the changes of health state before and after the intervention. Paretian Classification of Health Change (PCHC) and Health Profile Grid (HPG) will be used to summarize the change of the profile data. Linear regression models with mixed effect for both VAS and EQ5D dimension can be used to evaluate the effect of potential determinants and the effect of the programming. | EQ-5D-5L scores will be evaluated immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Community walkability as perceived by participants | The Physical Activity Neighborhood Environment Survey (PANES) provides estimates of self- reported neighbourhood, built environment supportiveness for physical activity with some degree of test-retest reliability and construct validity. The overall PANES score should have a range of 0 to 6, with higher values indicating greater environmental support for physical activity. For each item the investigators also have a dichotomized outcome to indicate whether strongly or somewhat agree with the statement. The mean and standard deviation will be presented for the overall PANES score and percentage of participants with strongly or somewhat agree with the statement in each item. Correlations of walkability index to physical activity and fitness (and changes within these categories) will be made. Indices will be compared between sites. | PANES scores will be will be collected immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant quality of life, sense of belonging and mental health - Secondary | Social well-being will be evaluated using Canadian Health Measures Survey (CHMS) sense of belonging question: GEN_Q18: How would you describe your sense of belonging to your local community? Would you say it is?
Very strong Somewhat strong Somewhat weak Very weak Percentage of participants in each category pre and post program will be compared and correlated with other outcome measures such as attendance, BMI, percent body fat, etc. Chi-square tests will be used to identify whether the programming will significantly change the participants' sense of belonging to their local community. Generalized linear mixed model will also be used for the repeated measurements collected pre and post program considering other potential factors such as age, income, medical history, location, education level and so on. |
Responses will be will be collected immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant Nutrition - Healthy Eating Index | The Healthy Eating Index (HEI) uses a scoring system to evaluate a set of foods. The score ranges from 0 to 100 points. The total HEI score is an indication of overall diet quality and changes in the HEI score will be used to determine whether dietary practices have improved throughout the intervention.
Component scores when examined together show a pattern of diet quality. The summary statistics including the mean and standard deviation for the overall HEI and each component, will be included and the index value will be used as covariates when evaluating the changes in outcomes such as weight, BMI (kg/m2), PAM. Etc. |
HEI scores will be will be evaluated immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant Nutrition - Traditional Foods | Individual questions adapted to address Indigenous population consumption of traditional foods and changes within this category. | A summary of traditional food consumption immediately pre-program (Week 1; Time 1) and after the full program (Week 18 or 24; Time 3) will be completed. | |
Secondary | Participant Nutrition - Health Education | Nutrition knowledge: Questions developed based on the Health Education Modules with a focus on nutrition elements. Questions: Do you understand how to 'balance your diet'? Have you learned new recipes, methods of cooking, or methods for storage of food that will help you plan your meals (follow by 'give examples please')? Do you understand the difference between proteins, fats and carbohydrates and foods that provide these nutrients? Health knowledge is assessed at the end of the program and one year later to determine changes to knowledge over time. | Changes in nutrition knowledge will be summarized and evaluated after the full program (Week 18 or 24; Time 3) and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Participant Nutrition - Food Security | Food security will be evaluated using the 2-Item Food Security Screen. Percentage positively responding to food security questions and change over time will be completed and correlated with other outcome measures including nutritional intake, anthropometric changes, mental health and quality of life. | Food Security scores will be evaluated immediately pre-program (Week1; Time 1), after the live program (12 weeks; Time 2), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Awareness and access to previously unused or unknown resources | Open-ended (qualitative) survey questions will assess if there are resources (ie. medical, mental health, cultural programming, recreational, food, social, etc.) that the participant faces barriers to accessing and whether their use of these resources changes with their participation in the program.
This information will be reported in a table and will be provided to communities after the project is complete. |
Access to resources will be evaluated immediately pre-program (Week1; Time 1), after the full program (Week 18 or 24; Time 3), and 52 weeks after the full program (Week 70 or 76; Time 4). | |
Secondary | Attendance | The investigators will present attendance rates as # participants/program, # attending <25%, 25- 50%, 50-75% and >75% of classes (mean attendance with range), a participant is defined as attending a program if they attended 50% or greater of the classes. | Attendance is tracked throughout the program and ultimately evaluated at the end of the program (Week 18 or 24; Time 3). |
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