Do PA Interventions Increase Acute Medical Inpatients PA Levels

Physical Activity Clinical Trial

Official title:

Do Physical Activity (PA) Interventions Increase Acute Medical Inpatients Self-reported Physical Activity Levels (PAL): A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383054
• Other study ID #: 19AM006
• Status: Completed
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: October 13, 2021

Study information

• Verified date: October 2023
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 13, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Medical Unit
• Moving Medicine
• Physical Activity

Intervention

Behavioral:
• '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).
• '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).

Locations

Country	Name	City	State
United Kingdom	Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	12 weeks
Secondary	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.	baseline
Secondary	recruitment rate	the number of days taken to recruit 50 participants	1-2 months
Secondary	retention rate	the number of participants who complete the 4 and 12 week follow-up points	3 months