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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03709212
Other study ID # KCH-CULTURE CKD
Secondary ID 241792KCH18-053
Status Completed
Phase
First received
Last updated
Start date May 31, 2018
Est. completion date December 30, 2019

Study information

Verified date October 2018
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United Kingdom King's College Hospital London

Sponsors (3)

Lead Sponsor Collaborator
King's College Hospital NHS Trust British Renal Society, Kidney Care UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Through study completion, an average of one year
Primary 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.
Through study completion, an average of one year
Secondary 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.
Through study completion, an average of one year
Secondary 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.
Through study completion, an average of one year
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