Chronic Conditions, MultipleNCT05287932
Brief Physical Activity Intervention for Older People With Multimorbidity
A study testing Brief physical activity intervention in people with Chronic Conditions, Multiple and Old Age; Debility, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Physical activity is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Conditions, Multiple, Old Age; Debility, Physical Inactivity
- What is being tested?
- Brief physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2022to 31 Aug 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥60 years
- 2 or more chronic conditions
- able to walk outside the home
- able to attend the study visits
Who cannot join
- living in a residential or nursing home
- housebound
- ≥3 falls in previous year
- dementia or significant cognitive impairment (unable to follow simple instructions)
- contraindication to increasing physical activity
- unable to read or speak English
- unable to provide consent
- no more than one person per household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity
Physical activity is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. This preliminary study will explore the effects of a brief physical activity intervention on physical activity and physical function in older people with multimorbidity. The findings will be used to inform the design of a subsequent adequately-powered randomised controlled trial.
- Being tested
- Brief physical activity intervention
- Keywords
- Multimorbidity, Older people, Physical activity
- Medical subject headings
- Multiple Chronic Conditions, Frailty, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief physical activity interventionBehavioural
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Brief physical activity intervention including an initial 45-minute physical activity consultation, telephone support after 2 weeks (approx. 15-minute call), and provision of a pedometer, written information, and a physical activity diary. Embedded behaviour change techniques will include goal setting, self-monitoring, building self-efficacy and social support, and overcoming barriers. Receives: Behavioral: Brief physical activity intervention |
| Wait-list control | No intervention | The control group will not receive any active or placebo intervention during the 4-week study period. They will also not receive any trial contacts during this period. They will however continue to be able to access their usual care from primary, secondary, community, and social services. After the final (4-week) follow-up assessment, this group will receive the full physical activity intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily acceleration
Average acceleration from wrist accelerometry
Measured: 4 weeks
Secondary outcomes (9)
Intensity gradient
Intensity gradient from wrist accelerometry
Measured: 4 weeks
Time in MVPA
Average daily time spent in moderate-to-vigorous physical activity from wrist accelerometry
Measured: 4 weeks
Steps
Average daily step count
Measured: 4 weeks
Muscle strengthening exercise
Average daily time spent doing muscle strengthening exercise
Measured: 4 weeks
30-second chair rise performance
Number of sit-to-stand movements completed within 30 seconds
Measured: 4 weeks
Handgrip strength
Maximum handgrip strength measured on both hands using a Jamar handgrip dynamometer
Measured: 4 weeks
Timed 8ft up and go performance
Time to complete 8ft up and go test
Measured: 4 weeks
Timed single-leg balance performance
Time able to stand on one limb
Measured: 4 weeks
6-minute walk test performance
Total distance walked during 6-minute corridor walking test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start9 May 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Conditions, MultipleStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garry Tew, Northumbria University
- Investigators
- Garry A Tew, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287932
- Sponsor's protocol ID
- HLSGT030322
- Status last verified
- Sep 2022
- First submitted
- 10 Mar 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity
- ClinicalTrials.gov ID
- NCT05287932
- Acronym / sponsor ID
- HLSGT030322
- Keywords
- Multimorbidity, Older people, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 18 Mar 2022 (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 is an important determinant of health and well-being in older people. However, many older people do not achieve recommended physical activity levels and increasing older people's physical activity is challenging. This preliminary study will explore the effects of a brief physical activity intervention on physical activity and physical function in older people with multimorbidity. The findings will be used to inform the design of a subsequent adequately-powered randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief physical activity interventionBrief physical activity intervention including an initial 45-minute physical activity consultation, telephone support after 2 weeks (approx. 15-minute call), and provision of a pedometer, written information, and a physical activity diary. Embedded behaviour change techniques will include goal setting, self-monitoring, building self-efficacy and social support, and overcoming barriers. |
| Wait-list control | No intervention | –The control group will not receive any active or placebo intervention during the 4-week study period. They will also not receive any trial contacts during this period. They will however continue to be able to access their usual care from primary, secondary, community, and social services. After the final (4-week) follow-up assessment, this group will receive the full physical activity intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged ≥60 years
- 2 or more chronic conditions
- able to walk outside the home
- able to attend the study visits
Key exclusion criteria (8 listed)
- living in a residential or nursing home
- housebound
- ≥3 falls in previous year
- dementia or significant cognitive impairment (unable to follow simple instructions)
- contraindication to increasing physical activity
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 |
|---|---|---|
| Brief physical activity interventionSee arm/group descriptions | Behavioural | Intervention |
Primary outcome
Average daily acceleration
Time frame: 4 weeks
Average acceleration from wrist accelerometry
9 secondary outcomes
Intensity gradient
Time frame: 4 weeks
Time in MVPA
Time frame: 4 weeks
Steps
Time frame: 4 weeks
Muscle strengthening exercise
Time frame: 4 weeks
30-second chair rise performance
Time frame: 4 weeks
Handgrip strength
Time frame: 4 weeks
Timed 8ft up and go performance
Time frame: 4 weeks
Timed single-leg balance performance
Time frame: 4 weeks
6-minute walk test performance
Time frame: 4 weeks
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 27 Sep 2022.
- Individual participant dataSharing planned: Yes. External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.
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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.
Garry A Tew, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief physical activity intervention in people with Chronic Conditions, Multiple and Old Age; Debility, run by Northumbria University 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 8 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 27 Sep 2022. 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?
Average daily acceleration (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 27 Sep 2022; AzTrials last refreshed its copy on 2 Nov 2026.