Physical ActivityNCT04383054
Do PA Interventions Increase Acute Medical Inpatients PA Levels
A study testing 'More minutes' conversation (Moving medicine) and 'one minute' conversation (Moving medicine) in people with Physical Activity and Moving Medicine, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Physical activity (PA) can help treat and prevent many physical and mental health conditions. However, many of the United Kingdom population do not meet the Department of Health's PA recommendations which is contributing to the high chronic disease burden in the UK population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Moving Medicine, Acute Medical Unit
- What is being tested?
- 'More minutes' conversation (Moving medicine) and 'one minute' conversation (Moving medicine)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2020to 13 Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- Ability to give informed consent.
- Patients equal or greater than 18 years of age.
- Patients identified by ward staff as being about to be discharged from hospital over the coming day(s).
- Patients identified by ward staff as being able to walk 10m on flat ground, with or without a walking aid.
Who cannot join
- Patients who do not understand verbal and written English.
- Patients who currently meet the Department of Health's current aerobic physical activity recommendations as assessed by the GPAQ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Physical Activity (PA) Interventions Increase Acute Medical Inpatients Self-reported Physical Activity Levels (PAL): A Feasibility Study
Physical activity (PA) can help treat and prevent many physical and mental health conditions. However, many of the United Kingdom population do not meet the Department of Health's PA recommendations which is contributing to the high chronic disease burden in the UK population. Many patients who are admitted to acute medical wards have at least one co- morbidity. Inpatients on acute hospital wards do not routinely receive PA advice from healthcare staff. The investigators believe that patients could be encouraged to increase their PA level (PAL) during an admission to hospital.
Read the detailed description
The investigators have undertaken two previous qualitative studies that proceed this work. The first study found that patients were open to discussing PA during admission to an acute medical unit (AMU). In the second study patients thought motivational interviews focused on PA helped them increase their PAL. Although patients have reported that motivational interviews were beneficial in helping them increase their PA, this has so far not been assessed quantitatively.
The investigators plan to recruit 50-100 patients and randomise them into two groups. One group will receive a short PA intervention and the other a long intervention. The investigators will use the moving medicine online resource to structure both PA intervention. The 'one minute' conversation will be used for the short PA intervention and the 'more minutes' conversation for the long PA intervention. The investigators will measure the PAL of both groups at baseline and at two follow-up points (4 weeks and 12 weeks). The Global Physical Activity Questionnaire will be used to assess participants self-reported PAL. The data collected will be used to describe participants baseline PAL and the treatment effect of the two PA interventions. The investigators will also calculate estimated recruitment and retention rates. The results of this feasibility study will be used to plan a similarly designed powered randomised controlled trial.
- Conditions
- Physical Activity, Moving Medicine, Acute Medical Unit
- Being tested
- 'More minutes' conversation (Moving medicine), 'one minute' conversation (Moving medicine)
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'More minutes' conversation (Moving medicine)Behavioural
For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine).
'one minute' conversation (Moving medicine)Behavioural
For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine).
| Study group | Role | What they receive |
|---|---|---|
| Long PA intervention group | Experimental | The long PA intervention will be a MI (motivational interview) exploring the participant's knowledge and concerns about PA. An MI involves a semi-structured discussion between an investigator and the participant. The MI initially explores the participant's knowledge of the benefits of PA and their concerns about PA. The MI will then explore the participant's confidence in increasing their PAL, help the participant come up with a plan to increase their PAL and finally the participant will be signposted to further support and local opportunities for PA. The investigator will use a Moving Medicine 'more minutes' conversation tool of a chronic health condition that the patient has to facilitate every MI. Where possible the investigator will discuss the chronic condition that most relates to the participant's current admission to hospital. For patients with no health conditions the primary prevention section will be used. Receives: Behavioral: 'More minutes' conversation (Moving medicine) |
| Short PA intervention group | Active comparator | The short PA intervention will involve a short (1 min) discussion between an investigator and a participant. A Moving Medicine 'one minute' intervention appropriate to the participant's health conditions will be used to guide every short intervention. The short intervention will firstly involve the investigator asking whether the participant knew that doing PA was beneficial for their health. The investigator would then explain to be more PA they could try to build more PA into their daily routine and that this was often enough to meet the current PA recommendations. The investigator will also offer the participant a patient information sheet about PA. Receives: Behavioral: 'one minute' conversation (Moving medicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's self reported Metabolic Equivalents (METs) at 4 weeks assessed using the Global Physical Activity Questionnaire.
The primary outcome is the participant's physical activity level (PAL) at the 4 week follow-up point. The investigators will use the Global Physical Activity Questionnaire (GPAQ) to assess participant's PAL. The GPAQ will be analysed using the GPAQ analysis guide to provide a result in Metabolic Equivalents (METs). MET is the ratio of a person's working metabolic rate relative to the resting metabolic rate and is commonly used to express the intensity of physical activities. One MET is defined as the energy cost of sitting quietly. MET is therefore a linear scale of physical activity (PA) from 0 upwards with no maximum value. The higher the MET the more PA a person is doing. The Department of Health advise adults to do a combination of moderate to vigorous PA totalling 150 minutes of moderate PA or 75 minutes of vigorous PA a week (or a combination of both). The approximate MET equivalent of 150 minutes of moderate intensity PA is 600 METs
Measured: 4 weeks
Secondary outcomes (4)
Participant's self reported Metabolic Equivalents (METs) at 12 weeks assessed using the Global Physical Activity Questionnaire
The primary outcome is the participant's physical activity level (PAL) at the 12 week follow-up point. The investigators will use the Global Physical Activity Questionnaire (GPAQ) to assess participant's PAL.The GPAQ will be analysed using the GPAQ analysis guide to provide a result in Metabolic Equivalents (METs). MET is the ratio of a person's working metabolic rate relative to the resting metabolic rate and is commonly used to express the intensity of physical activities. One MET is defined as the energy cost of sitting quietly. MET is therefore a linear scale of physical activity (PA) from 0 upwards with no maximum value. The higher the MET the more PA a person is doing. The Department of Health advise adults to do a combination of moderate to vigorous PA totalling 150 minutes of moderate PA or 75 minutes of vigorous PA a week (or a combination of both). The approximate MET equivalent of 150 minutes of moderate intensity PA is 600 METs
Measured: 12 weeks
physical activity level at baseline
The primary outcome is the participant's physical activity level at baseline. The investigators will use the Global Physical Activity Questionnaire (GPAQ) to assess participant's physical activity level. The GPAQ will be analysed using the GPAQ analysis guide to provides a result in a METs.
Measured: baseline
recruitment rate
the number of days taken to recruit 50 participants
Measured: 1-2 months
retention rate
the number of participants who complete the 4 and 12 week follow-up points
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start24 Aug 2020
- Primary completion11 Jun 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383054
- Sponsor's protocol ID
- 19AM006
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Physical Activity (PA) Interventions Increase Acute Medical Inpatients Self-reported Physical Activity Levels (PAL): A Feasibility Study
- ClinicalTrials.gov ID
- NCT04383054
- Acronym / sponsor ID
- 19AM006
- Conditions
- Physical Activity, Moving Medicine, Acute Medical Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 11 May 2020 (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.
Physical activity (PA) can help treat and prevent many physical and mental health conditions. However, many of the United Kingdom population do not meet the Department of Health's PA recommendations which is contributing to the high chronic disease burden in the UK population. Many patients who are admitted to acute medical wards have at least one co- morbidity. Inpatients on acute hospital wards do not routinely receive PA advice from healthcare staff. The investigators believe that patients could be encouraged to increase their PA level (PAL) during an admission to hospital.
Detailed description
The investigators have undertaken two previous qualitative studies that proceed this work. The first study found that patients were open to discussing PA during admission to an acute medical unit (AMU). In the second study patients thought motivational interviews focused on PA helped them increase their PAL. Although patients have reported that motivational interviews were beneficial in helping them increase their PA, this has so far not been assessed quantitatively.
The investigators plan to recruit 50-100 patients and randomise them into two groups. One group will receive a short PA intervention and the other a long intervention. The investigators will use the moving medicine online resource to structure both PA intervention. The 'one minute' conversation will be used for the short PA intervention and the 'more minutes' conversation for the long PA intervention. The investigators will measure the PAL of both groups at baseline and at two follow-up points (4 weeks and 12 weeks). The Global Physical Activity Questionnaire will be used to assess participants self-reported PAL. The data collected will be used to describe participants baseline PAL and the treatment effect of the two PA interventions. The investigators will also calculate estimated recruitment and retention rates. The results of this feasibility study will be used to plan a similarly designed powered randomised controlled trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long PA intervention group | Experimental | Behavioral: 'More minutes' conversation (Moving medicine)The long PA intervention will be a MI (motivational interview) exploring the participant's knowledge and concerns about PA. An MI involves a semi-structured discussion between an investigator and the participant. The MI initially explores the participant's knowledge of the benefits of PA and their concerns about PA. The MI will then explore the participant's confidence in increasing their PAL, help the participant come up with a plan to increase their PAL and finally the participant will be signposted to further support and local opportunities for PA. The investigator will use a Moving Medicine 'more minutes' conversation tool of a chronic health condition that the patient has to facilitate every MI. Where possible the investigator will discuss the chronic condition that most relates to the participant's current admission to hospital. For patients with no health conditions the primary prevention section will be used. |
| Short PA intervention group | Active comparator | Behavioral: 'one minute' conversation (Moving medicine)The short PA intervention will involve a short (1 min) discussion between an investigator and a participant. A Moving Medicine 'one minute' intervention appropriate to the participant's health conditions will be used to guide every short intervention. The short intervention will firstly involve the investigator asking whether the participant knew that doing PA was beneficial for their health. The investigator would then explain to be more PA they could try to build more PA into their daily routine and that this was often enough to meet the current PA recommendations. The investigator will also offer the participant a patient information sheet about PA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to give informed consent.
- Patients equal or greater than 18 years of age.
- Patients identified by ward staff as being about to be discharged from hospital over the coming day(s).
- Patients identified by ward staff as being able to walk 10m on flat ground, with or without a walking aid.
Key exclusion criteria (2 listed)
- Patients who do not understand verbal and written English.
- Patients who currently meet the Department of Health's current aerobic physical activity recommendations as assessed by the GPAQ.
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 |
|---|---|---|
| 'More minutes' conversation (Moving medicine)For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine). | Behavioural | Long PA intervention group |
| 'one minute' conversation (Moving medicine)For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine). | Behavioural | Short PA intervention group |
Primary outcome
Participant's self reported Metabolic Equivalents (METs) at 4 weeks assessed using the Global Physical Activity Questionnaire.
Time frame: 4 weeks
The primary outcome is the participant's physical activity level (PAL) at the 4 week follow-up point. The investigators will use the Global Physical Activity Questionnaire (GPAQ) to assess participant's PAL. The GPAQ will be analysed using the GPAQ analysis guide to provide a result in Metabolic Equivalents (METs). MET is the ratio of a person's working metabolic rate relative to the resting metabolic rate and is commonly used to express the intensity of physical activities. One MET is defined as the energy cost of sitting quietly. MET is therefore a linear scale of physical activity (PA) from 0 upwards with no maximum value. The higher the MET the more PA a person is doing. The Department of Health advise adults to do a combination of moderate to vigorous PA totalling 150 minutes of moderate PA or 75 minutes of vigorous PA a week (or a combination of both). The approximate MET equivalent of 150 minutes of moderate intensity PA is 600 METs
4 secondary outcomes
Participant's self reported Metabolic Equivalents (METs) at 12 weeks assessed using the Global Physical Activity Questionnaire
Time frame: 12 weeks
physical activity level at baseline
Time frame: baseline
recruitment rate
Time frame: 1-2 months
retention rate
Time frame: 3 months
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 6 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'More minutes' conversation (Moving medicine) and 'one minute' conversation (Moving medicine) in people with Physical Activity and Moving Medicine, run by Nottingham University Hospitals 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 4 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 6 Oct 2023. 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?
Participant's self reported Metabolic Equivalents (METs) at 4 weeks assessed using the Global Physical Activity Questionnaire. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.