- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709212
Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease (CULTURE-CKD)
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
This present study will utilise Stokol's Social Ecological Theory of Health Behaviour as the main theoretical framework. This multi-level Ecological theory suggests that an individual's behaviour results from a complex interaction between the individual, the environment, and community in which they live. Multi-level theories are thought to be more robust and explanatory, in comparison to single-level approaches as they are representative of the public health approach to population change. Ecological approaches such as Stokol's Social Ecological Theory form a robust base to evaluate complex multifactorial behaviours such as physical activity. This theory has been used, and is promoted for use, in designing community-level health programmes, such as physical activity interventions for different ethnic communities. David Howe, a sports anthropologist, will advise the research team with the interpretation of the data using this framework.
Purpose:
The purpose of this present study is to utilise a mixed-methods design to explore the understanding of physical activity and exercise, and factors that contribute to a decision to be physically active or sedentary, in patients with CKD from different ethnic backgrounds. The investigators intend to measure self-reported physical activity levels with the General Practice Physical Activity Questionnaire (GPPAQ) and self-efficacy for exercise (readiness to start doing exercise) with Bandura's self-efficacy for exercise scale. The investigators then aim to explore perceptions, attitudes and values about physical activity and exercise therapy in different ethnic groups. The investigators will ensure that views are captured from patients stratified by activity, readiness to be active, age and gender. To accomplish these goals, the present study will explore: (i) the understanding of the terms 'physical activity' and 'exercise'; (ii) the interpretation of the socio-cultural contexts in which they choose (or not) to be physically active, and; (iii) the participants understanding of physical activity and exercise opportunities and barriers in their local environment. All questionnaires will be translated for non-English speaking participants, and individual and focus group discussions will be facilitated with translators.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SE5 9RS
- King's College Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants with a diagnosis of CKD that are representative of one of the 3 ethnic groups that will be studied (Black African and African-Caribbean; South Asian, and White Caucasian patients)
- Age > 18 years of age
- able to provide Informed consent
Exclusion Criteria:
- Uncontrolled medical condition (e.g. uncontrolled angina)
- Unstable psychiatric condition
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Individual semi-structured interview
20 participants will undergo individual semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this. Participants will be recruited from three ethnic backgrounds; Black African/ Caribbean, South Asian and White Caucasian. |
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
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Focus Group 1
10 participants female black African/ African Caribbean ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
|
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
Focus Group 2
10 participants male Black African/ African Caribbean ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
|
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
Focus Group 3
10 participants female South Asian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
|
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
Focus Group 4
10 participants male black South Asian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
|
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
Focus Group 5
10 participants female White Caucasian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
|
20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
Focus Group 6
10 participants male White Caucasian ethnicity will undergo group semi-structured interviews to explore perceptions of living with Chronic Kidney Disease, attitudes and understanding of exercise and physical activity and any cultural influences that may influence attitudes or decisions regarding this.
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20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One-to-one semi-structured interview to explore participants experiences of living with Chronic Kidney Disease.
Time Frame: Through study completion, an average of one year
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To establish challenges and perceptions of living with this long term condition and how this has an impact on day to day life.
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Through study completion, an average of one year
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One-to-one semi-structured interview to explore participants experience of exercise and physical activity
Time Frame: Through study completion, an average of one year
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Any difficulties/ barriers to exercise or physical activity determined by a qualitative interview. Experiences of the exercise and physical activity by a qualitative interview. Benefits to under taking physical activity and exercise by a qualitative interview. Facilities and opportunities available to undertake exercise of physical activity by a qualitative interview. Any cultural influences that may have influenced decisions to participate in physical activity and exercise by a qualitative interview. |
Through study completion, an average of one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity through General Practice Physical Activity Questionnaire (GPPAQ)
Time Frame: Through study completion, an average of one year
|
GPPAQ is a reliable and validated questionnaire used to measure adult physical activity levels. It contains seven questions and provides a simple, 4-level Physical Activity Index (PAI) of: Active, Moderately Active, Moderately Inactive, and Inactive. PAI scale from question answers range from 'inactive' which indicates a sedentary job and no physical exercise or cycling. This scale then ranges through to 'active' indicates a sedentary job and ≥ 3 hours physical exercise OR a standing job and 1-2.9 hours physical exercise per week OR a physical job and some but < 1 hour physical exercise per week. The classification of Physical Activity Index gives an indication of how active an adult individual is on a weekly basis. |
Through study completion, an average of one year
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Self-efficacy to regulate exercise
Time Frame: Through study completion, an average of one year
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Bandura self-efficacy for exercise scale This questionnaire contains 18 questions to answer with regards to self-efficacy to exercise on a scale of 0-100. The questions relate to the certainty of the participant to continue with a regular exercise routine (three or more times a week) in relation to the questions posed. In relation to the scale 0 is 'cannot do at all' and 100 is 'highly certain can do'. The total score is calculated by summing the responses to each question. The scale has a range of total scores from 0-1,800. A higher score indicates greater exercise related self-efficacy. |
Through study completion, an average of one year
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Collaborators and Investigators
Investigators
- Study Chair: Sharlene A Greenwood, PhD, BSc, King's College Hospital NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCH-CULTURE CKD
- 241792 (Other Identifier: IRAS number)
- KCH18-053 (Other Identifier: Sponsor site reference number (King's College Hospital))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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