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Increasing physical activity in a medium secure service

Increasing physical activity in a medium secure service: the development and feasibility of a physical activity intervention (IMPACT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15546527
Enrollment
302
Registered
2021-05-28
Start date
2021-11-25
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical activity of people in medium secure mental health units Other

Interventions

This is a 24-month mixed-methods project that will follow the Medical Research Council (MRC) framework Developing and Evaluating Complex Interventions as it provides guidance for the systematic develo

Sponsors

South West Yorkshire Partnership NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Phase 1: Service user questionnaire and staff focus groups Service users: 1. Aged 18+ years 2. Have mental capacity to give informed consent (through discussion with the multi-disciplinary team) 3. Sufficient command of English to complete the questionnaire Staff: 1. Aged 18+ years 2. Qualified and unqualified staff from both study sites that have worked in the service for at least 3 months Phase 2: Stakeholder and service user focus group Service users: 1. Aged 18+ years 2. Have mental capacity to give informed consent (through discussion with the multi-disciplinary team) 3. Sufficient command of English to participate in a focus group Staff: 1. Aged 18+ years 2. Qualified and unqualified staff from both study sites that have worked in the service for at least 3 months 3. Professionals with expertise in interventions to promote physical activity and behaviour change interventions Phase 3: Intervention development group Service users: 1. Aged 18+ years 2. Have mental capacity to give informed consent (through discussion with the multi-disciplinary team) 3. Sufficient command of English to participate in a focus group Staff and stakeholders: 1. Aged 18+ years 2. Qualified and unqualified staff from both study sites that have worked in the service for at least 3 months 3. Professionals with expertise in interventions to promote physical activity and behaviour change interventions Phase 4: Feasibility study with service users and staff Service users: 1. Aged 18+ years 2. Have mental capacity to give informed consent (through discussion with the multi-disciplinary team) 3. Sufficient command of English to participate, complete the assessments (alone or with help of researcher) and complete interviews 4. Is an in-patient for 12 months or more Staff: 1. Aged 18+ years 2. Qualified and unqualified staff from both study sites that have had direct contact with participants who received the treatment intervention 3. Exercise and occupational therapists who deliver the intervention at each study site

Exclusion criteria

Exclusion criteria: Phase 1: Service user questionnaire and staff focus groups Service users: 1. Age under 18 years 2. Unable to provide informed consent 3. Insufficient command of English to complete a questionnaire 4. Pose a significant risk to self and/or others Staff: 1. Age under 18 years 2. Qualified and unqualified staff from both study sites that have not worked in the service for at least 3 months Phase 2: Stakeholder and service user focus group Service users: 1. Age under 18 years 2. Unable to provide informed consent 3. Insufficient command of English to participate in a focus group 4. Pose a significant risk to self and/or others Staff: 1. Age under 18 years 2. Qualified and unqualified staff from both study sites that have not worked in the service for at least 3 months 3. Professionals with no expertise in interventions to promote physical activity and behaviour change interventions Phase 3: Intervention development group Service users: 1. Age under 18 years 2. Unable to provide informed consent 3. Insufficient command of English to participate in a focus group 4. Pose a significant risk to self and/or others Staff and stakeholders: 1. Age under 18 years 2. Qualified and unqualified staff from both study sites that have not worked in the service for at least 3 months 3. Professionals with no expertise in interventions to promote physical activity and behaviour change interventions Phase 4: Feasibility study with service users and staff Service users: 1. Age under 18 years 2. Unable to provide informed consent 3. Insufficient command of English to participate 4. Pose a significant risk to self and/or others 5. Is an in-patient for less than 12 months Staff: 1. Age under 18 years 2. Qualified and unqualified staff from both study sites that have not had direct contact with participants who received the treatment intervention 3. Exercise and occupational therapists who did not deliver the intervention at each study site

Design outcomes

Primary

MeasureTime frame
All measured at the completion of the study: 1. Participant recruitment rate: the proportion of eligible patients who accept the invitation to participate in the research study 2. Retention and adherence: the proportion of participants who complete the study and the proportion of intervention sessions completed 3. The acceptability of the intervention, study design and outcome measures as well as participants’ and staff experiences with the intervention, assessed qualitatively using focus group and interview data for patient and staff groups analysed using framework analysis 4. Descriptive statistics for each outcome measure at week 0, 12, 16 and 28

Secondary

MeasureTime frame
1. Body Mass Index, body fat and muscle measured using the Tanita weight machine at week 0, 12, 16 and 28 2. Resting pulse rate (beats per minute) measured using the Home Step test at week 0, 12, 16 and 28 3. Perceived exertion measuredusing the Borg ten-point scale at week 0, 12, 16 and 28 4. Cardiac and metabolic health measured using the Lester Tool at week 0, 12, 16 and 28 5. Review of prescribed Medication and Diagnosis record and compared against reported side-effects as documented within the British National Formulary and a discussion with service users at week 0, 12, 16 and 28 6. Motivational profile of exercise and training measured using the Behaviour Regulation in Exercise Questionnaire-2 (BREQ-2) at week 0, 12, 16 and 28 7. Three dimensions of physical activity (frequency, duration, and intensity) over the past 7 days measured using the New Zealand Physical Activity Questionnaire Short form (NZPAQ-SF) at week 0, 12, 16 and 28 8. Number of steps, distance, active minutes, and calories burned measured using a Fitbit Zip activity tracking device at week 0, 12, 16 and 28

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026