Cultural Influences on Physical Activity and Exercise Beliefs in Patients With Chronic Kidney Disease (CULTURE-CKD)

February 26, 2020 updated by: King's College Hospital NHS Trust
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

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

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital

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

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups
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.
Other: interviews
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:
  • individual semi-structured
  • Focus groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
To establish challenges and perceptions of living with this long term condition and how this has an impact on day to day life.
Through study completion, an average of one year
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.
Through study completion, an average of one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Self-efficacy to regulate exercise
Time Frame: Through study completion, an average of one year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College Hospital NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
British Renal Society
Kidney Care UK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sharlene A Greenwood, PhD, BSc, King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

within 12 months of study completion

IPD Sharing Access Criteria

with open access publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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