Chronic Kidney DiseasesCULTURE-CKDNCT03709212
Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Physical Activity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD) remains the leading cause of death in patients with Chronic Kidney Disease (CKD). Patients who spend a lot of time being inactive have an increased chance of developing CVD. Thus, interventions that can help to increase the levels of physical activity in patients with CKD are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Physical Activity, Exercise Therapy
- What is being tested?
- interviews
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2018to 30 Dec 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators aim to recruit up to 20 patients (for the individual interviews) and 60 patients (for the 6 single-sex focus groups), aged over 18 years or over with CKD from the 3 identified ethnic groups, will be recruited to the study. Each patient must have met the inclusion and exclusion criteria at entry level to the study. For focus groups the investigators will aim to meet with six to twelve participants per group. Appropriate topic guides will be developed and discussed with the patient advisory group, and the steering group. The investigators will continue with individual interviews and focus groups until data saturation is reached, there is no new data, no new themes, no new coding and the investigators are able to replicate the study.
Who may be able to join
- 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
Who cannot join
- Uncontrolled medical condition (e.g. uncontrolled angina)
- Unstable psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Cardiovascular disease (CVD) remains the leading cause of death in patients with Chronic Kidney Disease (CKD). Patients who spend a lot of time being inactive have an increased chance of developing CVD. Thus, interventions that can help to increase the levels of physical activity in patients with CKD are needed. A recent study the investigators completed with kidney transplant participants showed a benefit from the investigators supervised exercise programme. However, the investigators results showed that 11 of the 18 patients who dropped out from the 12-month study were from black and minority ethnic groups. Some patient feedback from these participants suggested that cultural beliefs; including women not being comfortable to exercise in front of men in an exercise class environment, and difficulties around appropriate dress for exercise classes, contributed to some of these participants' decisions to withdraw from the study. This has prompted the investigators to investigate, the cultural influences that may contribute to patient decisions about partaking in physical activity and exercise training. The aim of this study is therefore to invite patients with CKD from the three most widely represented ethnic groups found in our South-East London Hospital Trust (Black African and African-Caribbean; South Asian, and White Caucasian patients) to discuss their beliefs and the cultural influences that may affect their decision on whether to engage with exercise and physical activity. Participants will complete a questionnaire on physical activity levels, and a questionnaire that looks at a patient's readiness to be involved in physical activity, prior to attending interviews or group discussions. The questionnaires will be translated for use with non-English speaking participants and will be used to ensure we get views on physical activity from those participants who are active and not, and ready to be involved in physical activity, and not. A combination of individual interviews and group discussions will then be used to explore the understanding of the terms 'physical activity' and 'exercise', and cultural barriers to participation. The investigators will have interpreters present for all discussions, undertaken in the community. The work from this pilot study will be used to inform and design a larger multi-centre study with an aim to design physical interventions that are culturally sensitive, and appropriate for all patients with CKD in the United Kingdom.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Physical Activity, Exercise Therapy
- Being tested
- interviews
- Keywords
- Chronic Kidney Disease, Physical Activity, Cultural influences, Exercise
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewsOther
Also called individual semi-structured, Focus groups
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews | |
| 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. Receives: Other: interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-to-one semi-structured interview to explore participants experiences of living with Chronic Kidney Disease.
To establish challenges and perceptions of living with this long term condition and how this has an impact on day to day life.
Measured: Through study completion, an average of one year
One-to-one semi-structured interview to explore participants experience of exercise and physical activity
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.
Measured: Through study completion, an average of one year
Secondary outcomes (2)
Physical activity through General Practice Physical Activity Questionnaire (GPPAQ)
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.
Measured: Through study completion, an average of one year
Self-efficacy to regulate exercise
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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start31 May 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
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 Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Kidney Care UK, British Renal Society
- Responsible party
- Sponsor
- Investigators
- Sharlene A Greenwood, PhD, BSc, Study chair, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709212
- Sponsor's protocol ID
- KCH-CULTURE CKD
- Other IDs
- 241792, KCH18-053
- Acronym
- CULTURE-CKD
- Status last verified
- Oct 2018
- First submitted
- 8 Aug 2018
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study group plans to make anonymised data available as supplementary text when the study is published as an online manuscript. For example Plos one
Publications
Mayes J, Castle EM, Greenwood J, Ormandy P, Howe PD, Greenwood SA. Cultural influences on physical activity and exercise beliefs in patients with chronic kidney disease: 'The Culture-CKD Study'-a qualitative study. BMJ Open. 2022 Jan 11;12(1):e046950. doi: 10.1136/bmjopen-2020-046950.
PubMed 35017229
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03709212
- Acronym / sponsor ID
- CULTURE-CKD / KCH-CULTURE CKD
- Conditions
- Chronic Kidney Diseases, Physical Activity, Exercise Therapy
- Keywords
- Chronic Kidney Disease, Physical Activity, Cultural influences, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Kidney Care UK, British Renal Society
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (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.
Cardiovascular disease (CVD) remains the leading cause of death in patients with Chronic Kidney Disease (CKD). Patients who spend a lot of time being inactive have an increased chance of developing CVD. Thus, interventions that can help to increase the levels of physical activity in patients with CKD are needed. A recent study the investigators completed with kidney transplant participants showed a benefit from the investigators supervised exercise programme. However, the investigators results showed that 11 of the 18 patients who dropped out from the 12-month study were from black and minority ethnic groups. Some patient feedback from these participants suggested that cultural beliefs; including women not being comfortable to exercise in front of men in an exercise class environment, and difficulties around appropriate dress for exercise classes, contributed to some of these participants' decisions to withdraw from the study. This has prompted the investigators to investigate, the cultural influences that may contribute to patient decisions about partaking in physical activity and exercise training. The aim of this study is therefore to invite patients with CKD from the three most widely represented ethnic groups found in our South-East London Hospital Trust (Black African and African-Caribbean; South Asian, and White Caucasian patients) to discuss their beliefs and the cultural influences that may affect their decision on whether to engage with exercise and physical activity. Participants will complete a questionnaire on physical activity levels, and a questionnaire that looks at a patient's readiness to be involved in physical activity, prior to attending interviews or group discussions. The questionnaires will be translated for use with non-English speaking participants and will be used to ensure we get views on physical activity from those participants who are active and not, and ready to be involved in physical activity, and not. A combination of individual interviews and group discussions will then be used to explore the understanding of the terms 'physical activity' and 'exercise', and cultural barriers to participation. The investigators will have interpreters present for all discussions, undertaken in the community. The work from this pilot study will be used to inform and design a larger multi-centre study with an aim to design physical interventions that are culturally sensitive, and appropriate for all patients with CKD in the United Kingdom.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Individual semi-structured interview | – | Other: interviews20 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. |
| Focus Group 1 | – | Other: interviews10 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. |
| Focus Group 2 | – | Other: interviews10 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. |
| Focus Group 3 | – | Other: interviews10 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. |
| Focus Group 4 | – | Other: interviews10 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. |
| Focus Group 5 | – | Other: interviews10 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. |
| Focus Group 6 | – | Other: interviews10 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to recruit up to 20 patients (for the individual interviews) and 60 patients (for the 6 single-sex focus groups), aged over 18 years or over with CKD from the 3 identified ethnic groups, will be recruited to the study. Each patient must have met the inclusion and exclusion criteria at entry level to the study. For focus groups the investigators will aim to meet with six to twelve participants per group. Appropriate topic guides will be developed and discussed with the patient advisory group, and the steering group. The investigators will continue with individual interviews and focus groups until data saturation is reached, there is no new data, no new themes, no new coding and the investigators are able to replicate the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Uncontrolled medical condition (e.g. uncontrolled angina)
- Unstable psychiatric condition
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 |
|---|---|---|
| interviewsAlso: individual semi-structured, Focus groups20 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 | Focus Group 1, Focus Group 2, Focus Group 3, Focus Group 4, Focus Group 5, Focus Group 6, Individual semi-structured interview |
Primary outcome
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
To establish challenges and perceptions of living with this long term condition and how this has an impact on day to day life.
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
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.
2 secondary outcomes
Physical activity through General Practice Physical Activity Questionnaire (GPPAQ)
Time frame: Through study completion, an average of one year
Self-efficacy to regulate exercise
Time frame: Through study completion, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Derived from this study: PubMed 35017229Mayes J, Castle EM, Greenwood J, Ormandy P, Howe PD, Greenwood SA. Cultural influences on physical activity and exercise beliefs in patients with chronic kidney disease: 'The Culture-CKD Study'-a qualitative study. BMJ Open. 2022 Jan 11;12(1):e046950. doi: 10.1136/bmjopen-2020-046950.
- Individual participant dataSharing planned: Yes. The study group plans to make anonymised data available as supplementary text when the study is published as an online manuscript. For example Plos one
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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.
Sharlene A Greenwood, PhD, BSc study chair
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Physical Activity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 27 Feb 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 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 NCT03709212, 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 27 Feb 2020.