Physical ActivityKAPANCT03824015
Keeping Adults Physically Active Feasibility Study
A study testing Keeping Adults Physically Active (KAPA) intervention in people with Physical Activity and Falls Prevention, run by University of Nottingham.
Trial summary
The Keeping Adults Physically Active (KAPA) feasibility study aimed to examine the feasibility and acceptability of the an intervention designed to encourage the continuation of physical activity following the completion of a Falls Management Exercise program. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Falls Prevention
- What is being tested?
- Keeping Adults Physically Active (KAPA) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 22 Apr 2018
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Postural Stability Instructors in Leicestershire, Rutland or Derby City who were delivering a Local Authority-commissioned Falls Management Exercise program and were participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL)study.
- Able to provide written informed consent.
- Enrolled on a Local Authority Falls Management Exercise program in Derby City, Rutland or Leicestershire Counties and participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Able to provide written informed consent.
Who cannot join
- Postural Stability Instructors delivering a falls prevention programme or Falls Management Exercise program that was not commissioned within Derby City, Rutland or Leicestershire Counties and not participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Unable to provide written informed consent
- KAPA participants
- Enrolled on a falls prevention programme or Falls Management Exercise program that was not commissioned within Derby City, Rutland or Leicestershire Counties and not participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Unable to provide written informed consent.
About this study
Official title: Keeping Adults Physically Active: Randomised Controlled Feasibility Study
The Keeping Adults Physically Active (KAPA) feasibility study aimed to examine the feasibility and acceptability of the an intervention designed to encourage the continuation of physical activity following the completion of a Falls Management Exercise program.
Read the detailed description
Background and premise:
Research shows that the continuation of physical activity wanes, and the positive health effects diminish, between eight-to-twelve months after the completion of community-based physical activity programs. A key finding of the Pro-Act 65 trial was that 24-months after the trial ended the beneficial effects of the Falls Management Exercise program diminished in the older people who reverted back to their old physical activity behaviours. Sustaining physical activity levels after the end of a structured physical activity program is critical to maintain any gains in functional status and falling risk. Furthermore, sustaining changes in physical activity behaviour is vital to the cost-effectiveness of physical activity interventions and to improve public health outcomes. Yet, little is known about what intervention components work best to promote the continuation of new physical activity behaviours once structured exercise programs have ceased. This suggests there is substantial opportunity to maintain the health and wellbeing of older people by implementing interventions that encourage the maintenance of physical activity.
The investigators have developed a complex evidence-based intervention that aims to engage older adults in positive physical activity behaviours after the completion of the Falls Management Exercise program. The intervention developed is based on the findings of a systematic review [PROSPERO registration: CDR42016038137] of physical activity maintenance interventions delivered to people aged 65 years and older and a review of national expert guidance on behaviour change. The intervention will be delivered to people who are exiting a 24-week community based Falls Management Exercise program within Leicestershire, Rutland Counties and Derby City and will be investigated in a feasibility trial.
The ProAct65+ trial shows that physical activity can be maintained for 12 months after the cessation of a Falls Management Exercise program. Data will be collected directly after the completion of the maintenance intervention which is also the six month time-point after the completion of the FaME program. Therefore it is possible that both the control and the intervention group may maintain their physical activity levels after the Falls Management Exercise program has ceased. Although maintenance may be higher in the intervention group, the treatment effect of the KAPA intervention will not be assessed due to the given timeframe of this study. However the feasibility trial will be used to collect the crucial data needed to inform a subsequent randomised control trial.
Study design:
The feasibility of the KAPA intervention was investigated in a two-arm, cluster randomised (clustering at the level of Postural Stability Instructor), multisite feasibility trial comparing the KAPA intervention with usual care controls conducted in 8 Falls Management Exercise classes nested within the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
Research Participants:
There were two types of study participants:
- Community dwelling Falls Management Exercise program service users aged 65 years or older (referred to as KAPA participants).
- Postural Stability Instructors who delivered Local Authority-commissioned Falls Management Exercise program in Derby City, Rutland or Leicestershire Counties (referred to as Postural Stability Instructors).
Intervention procedures:
KAPA participants who completed the 24-week commissioned Falls Management Exercise program received six sessions of PA motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructor's delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session.
Control arm: Service providers usual care package.
The feasibility of the KAPA intervention was assessed by:
Objective 1: Feasibility of the research methods were assessed by estimating the recruitment and retention rates of the Postural Stability Instructors and the Falls Management Exercise program recipients to participate in the feasibility study.
Objective 2: Feasibility of the KAPA intervention was assessed by attendance rates and telephone response rates to the KAPA intervention as recorded in the class registers.
Objective 3: Assessing acceptability of the KAPA intervention by:
- Conducting semi-structure interviews with the participants in receipt of the intervention and the Postural Stability Instructors delivering the intervention, to assess the acceptability of the intervention features and delivery modes.
- To investigate the acceptability of the KAPA training day to the Postural Stability Instructors via a training evaluation questionnaire.
Objective 4: Investigating intervention adherence by:
- Analysing the Postural Stability Instructors completion rates of the class registers.
- Evaluating whether the participants completed the physical activity diaries and achieved their physical activity goals as recorded in the monthly class registers.
- The KAPA participants were also asked whether they adhered with the KAPA intervention during semi-structured interviews.
Objective 5: Assessing fidelity through:
- Observations of the initial consultations and group sessions.
- Postural Stability Instructors were asked whether they made any modifications to the KAPA intervention during a semi-structured interview.
Objective 6: Investigating parameter estimates of moderate to vigorous physical activity, the usual care descriptive and a data collection tool to cost the KAPA intervention for a future definitive trial by:
- Estimating the potential effect size of moderate to vigorous physical activity and percentage of the KAPA participants meeting the recommended 150 minutes of moderate to vigorous physical activity per week between the KAPA intervention and usual care arms.
- Estimating the intraclass correlation coefficient for moderate to vigorous physical activity using the Phone-FITT questionnaire.
- Usual care was described by its intervention features, delivery modes and the behaviour change strategies included.
- Identifying tools and testing the feasibility of collecting the data needed to cost the KAPA intervention to enable a cost-effective analysis in a definitive trial.
Objective 7: Recording adverse events and assessing them for causality to determine if they are related to the delivery of the KAPA intervention.
- Conditions
- Physical Activity, Falls Prevention
- Being tested
- Keeping Adults Physically Active (KAPA) intervention, Usual Care
- Keywords
- Physical Activity, Older Adults, Behaviour maintenance, feasibility study, falls prevention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeping Adults Physically Active (KAPA) interventionBehavioural
The Keeping Adults Physically Active (KAPA) intervention included six 60-90 minute group motivational interviewing sessions which were supported by a pedometer and a file containing information about locally run physical activity services, a home exercise booklet and written information on different types of lifestyle and transport related physical activity. During sessions the KAPA participants created physical activity plans and reflected on their physical activity diaries and personal physical activity goals. Various sub-sets of behaviour change techniques were delivered to help support the participants in continuing to be active.
Usual CareOther
Usual care was delivered for the duration of the KAPA feasibility study. The usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package. Upon initiating the KAPA feasibility study it was unknown what the service provider would deliver as usual care. Therefore a study objective was to describe the usual care package delivered by the service providers.
| Study group | Role | What they receive |
|---|---|---|
| KAPA intervention arm | Experimental | KAPA participants who completed the 24-week commissioned Falls Management Exercise program received six sessions of motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructors delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session. Receives: Behavioral: Keeping Adults Physically Active (KAPA) intervention |
| Usual care | Other | The usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates in the intervention and control group
The researchers recorded the number of study sites, Postural Stability Instructors and KAPA participants invited and recruited into the feasibility study. Retention rates were recorded as the number of KAPA participants (i.e. intervention and usual care participants) who remained within the study and provided outcome data at the 6-month time point.
Measured: 6 months
Attendance rates to the KAPA intervention sessions
The Postural Stability Instructors documented in the class registers the KAPA participants' attendance at each of the monthly telephone or face-to-face community based KAPA intervention sessions. Class registers were used to record the number of face to face and telephone interactions with the participants.
Measured: 6 months
Assessing acceptability of the KAPA intervention: semi-structure interviews
Acceptability of the intervention was determined via semi-structure interviews with the participants in receipt of the intervention and the Postural Stability Instructors delivering the intervention, to assess the acceptability of the intervention features and delivery modes. Interview data was analysed using a framework analysis approach.
Measured: 12 months
Secondary outcomes (7)
Training evaluation of the KAPA training day
After receiving KAPAs training the Postural Stability Instructors completed a training evaluation form to assess the suitability and acceptability of the training content and materials.
Measured: 1 day
Adherence to key KAPA intervention strategies
The KAPA participant's adherence to the KAPA intervention was measured via completion of the physical activity diaries and achievement of monthly physical activity goals. The Postural Stability Instructors asked the participants if they had completed their diaries and achieved their goals during each face to face or telephone delivered KAPA intervention session. Participant responses were recorded by hand as a yes/no in the monthly class registers by the Postural Stability Instructors.
Measured: 6 months
Fidelity of the KAPA interventions delivery
Fidelity was assess via observations of the KAPA sessions, which were recorded on a fidelity checklist.
Measured: 6 months
Parameter estimates of moderate to vigorous physical activity and Intra Class Coefficient
Moderate to vigorous physical activity were collected using the Frequency Intensity Time Type (Phone-FITT) questionnaire at baseline and the 6-month time point.
The Phone-FITT questionnaire measures household, recreational and seasonal activities. It does not provide a scoring system to categorise physical activity intensity as being light, moderate or vigorous. The Phone-FITT scoring system was re-categorised in terms of physical activity intensity across all household, recreational and seasonal physical activity in accordance with the Chief Medical Officers physical activity guidelines.
The Phone-FITT questionnaire utilises ranges to estimate physical activity duration (e.g. 1-15 minutes). To calculate minutes of moderate to vigorous physical activity the median number within each range was coded to estimate minutes of weekly physical activity. Frequency was recorded in its absolute values (i.e. x3 week).
Measured: 6 months
Defining usual care
A interview survey approach was used to collect the data relating to usual care. The aim was to describe usual care according to the following key elements:
- Provide a brief description of usual care
- Describe the type of PA behaviours did usual care targeted.
- Describe the materials used to help deliver usual care.
- Description of the usual care procedures and supporting activities.
- Describe who delivered usual care.
- Describe the modes of delivery.
- Describe the location were the intervention was delivered.
- Provide details on the duration, frequency, intensity and number of contacts that usual care was delivered.
- Provide any details on tailoring or modifications to usual care. The researcher asked the Postural Stability Instructors open questions (either face to face or via phone) relating to each of these elements. The researcher completed the data collection form with the Postural Stability Instructors responses.
Measured: 6 months
Developing a cost proforma to cost KAPA for a definitive trial
Data relating to how much it cost to deliver the KAPA intervention was collected using cost proformas completed by the service providers (i.e. Postural Stability Instructors and their managers). Cost proformas collected data on the costs incurred by the service providers to deliver the KAPA intervention. The data collected from the providers included costs relating to staff wages, travel expenses, administration costs, venue hire, consumables and expenses incurred to attend the training day. In addition a researcher recorded the research costs incurred to deliver the training day (i.e. venue hire, training manuals, trainer wages and trainer travel expenses).
Measured: 9 months
The number of adverse events incurred in the KAPA intervention group.
All adverse events were recorded and monitored by the research team.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start5 Jan 2017
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Six sessions of motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructors delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Elizabeth Orton, Principal investigator, University of Nottingham and NIHR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824015
- Sponsor's protocol ID
- 16001
- Other IDs
- 16/LO/0396
- Acronym
- KAPA
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
PubMed 39360568Audsley S, Kendrick D, Logan P, Jones M, Orton E. A randomised feasibility study assessing an intervention to keep adults physically active after falls management exercise programmes end. Pilot Feasibility Stud. 2020 Mar 7;6:37. doi: 10.1186/s40814-020-00570-9. eCollection 2020.
PubMed 32161660
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping Adults Physically Active: Randomised Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT03824015
- Acronym / sponsor ID
- KAPA / 16001
- Conditions
- Physical Activity, Falls Prevention
- Keywords
- Physical Activity, Older Adults, Behaviour maintenance, feasibility study, falls prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 31 Jan 2019 (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.
The Keeping Adults Physically Active (KAPA) feasibility study aimed to examine the feasibility and acceptability of the an intervention designed to encourage the continuation of physical activity following the completion of a Falls Management Exercise program.
Detailed description
Background and premise:
Research shows that the continuation of physical activity wanes, and the positive health effects diminish, between eight-to-twelve months after the completion of community-based physical activity programs. A key finding of the Pro-Act 65 trial was that 24-months after the trial ended the beneficial effects of the Falls Management Exercise program diminished in the older people who reverted back to their old physical activity behaviours. Sustaining physical activity levels after the end of a structured physical activity program is critical to maintain any gains in functional status and falling risk. Furthermore, sustaining changes in physical activity behaviour is vital to the cost-effectiveness of physical activity interventions and to improve public health outcomes. Yet, little is known about what intervention components work best to promote the continuation of new physical activity behaviours once structured exercise programs have ceased. This suggests there is substantial opportunity to maintain the health and wellbeing of older people by implementing interventions that encourage the maintenance of physical activity.
The investigators have developed a complex evidence-based intervention that aims to engage older adults in positive physical activity behaviours after the completion of the Falls Management Exercise program. The intervention developed is based on the findings of a systematic review [PROSPERO registration: CDR42016038137] of physical activity maintenance interventions delivered to people aged 65 years and older and a review of national expert guidance on behaviour change. The intervention will be delivered to people who are exiting a 24-week community based Falls Management Exercise program within Leicestershire, Rutland Counties and Derby City and will be investigated in a feasibility trial.
The ProAct65+ trial shows that physical activity can be maintained for 12 months after the cessation of a Falls Management Exercise program. Data will be collected directly after the completion of the maintenance intervention which is also the six month time-point after the completion of the FaME program. Therefore it is possible that both the control and the intervention group may maintain their physical activity levels after the Falls Management Exercise program has ceased. Although maintenance may be higher in the intervention group, the treatment effect of the KAPA intervention will not be assessed due to the given timeframe of this study. However the feasibility trial will be used to collect the crucial data needed to inform a subsequent randomised control trial.
Study design:
The feasibility of the KAPA intervention was investigated in a two-arm, cluster randomised (clustering at the level of Postural Stability Instructor), multisite feasibility trial comparing the KAPA intervention with usual care controls conducted in 8 Falls Management Exercise classes nested within the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
Research Participants:
There were two types of study participants:
- Community dwelling Falls Management Exercise program service users aged 65 years or older (referred to as KAPA participants).
- Postural Stability Instructors who delivered Local Authority-commissioned Falls Management Exercise program in Derby City, Rutland or Leicestershire Counties (referred to as Postural Stability Instructors).
Intervention procedures:
KAPA participants who completed the 24-week commissioned Falls Management Exercise program received six sessions of PA motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructor's delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session.
Control arm: Service providers usual care package.
The feasibility of the KAPA intervention was assessed by:
Objective 1: Feasibility of the research methods were assessed by estimating the recruitment and retention rates of the Postural Stability Instructors and the Falls Management Exercise program recipients to participate in the feasibility study.
Objective 2: Feasibility of the KAPA intervention was assessed by attendance rates and telephone response rates to the KAPA intervention as recorded in the class registers.
Objective 3: Assessing acceptability of the KAPA intervention by:
- Conducting semi-structure interviews with the participants in receipt of the intervention and the Postural Stability Instructors delivering the intervention, to assess the acceptability of the intervention features and delivery modes.
- To investigate the acceptability of the KAPA training day to the Postural Stability Instructors via a training evaluation questionnaire.
Objective 4: Investigating intervention adherence by:
- Analysing the Postural Stability Instructors completion rates of the class registers.
- Evaluating whether the participants completed the physical activity diaries and achieved their physical activity goals as recorded in the monthly class registers.
- The KAPA participants were also asked whether they adhered with the KAPA intervention during semi-structured interviews.
Objective 5: Assessing fidelity through:
- Observations of the initial consultations and group sessions.
- Postural Stability Instructors were asked whether they made any modifications to the KAPA intervention during a semi-structured interview.
Objective 6: Investigating parameter estimates of moderate to vigorous physical activity, the usual care descriptive and a data collection tool to cost the KAPA intervention for a future definitive trial by:
- Estimating the potential effect size of moderate to vigorous physical activity and percentage of the KAPA participants meeting the recommended 150 minutes of moderate to vigorous physical activity per week between the KAPA intervention and usual care arms.
- Estimating the intraclass correlation coefficient for moderate to vigorous physical activity using the Phone-FITT questionnaire.
- Usual care was described by its intervention features, delivery modes and the behaviour change strategies included.
- Identifying tools and testing the feasibility of collecting the data needed to cost the KAPA intervention to enable a cost-effective analysis in a definitive trial.
Objective 7: Recording adverse events and assessing them for causality to determine if they are related to the delivery of the KAPA intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Six sessions of motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructors delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session.
| Arm | Type | Receives |
|---|---|---|
| KAPA intervention arm | Experimental | Behavioral: Keeping Adults Physically Active (KAPA) interventionKAPA participants who completed the 24-week commissioned Falls Management Exercise program received six sessions of motivational interviewing over a six-month period. KAPA intervention sessions were held in accessible, community venues located within the local authorities of Derby City, Leicestershire and Rutland Counties. The KAPA intervention was delivered face-to-face by Postural Stability Instructors, in a group setting, using motivational interviewing. Sessions lasted between 60 to 90 minutes. Postural Stability Instructors delivered KAPA intervention sessions by telephone if a participant did not, or was unable to, attend a face-to-face session. |
| Usual care | Other | Other: Usual CareThe usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Postural Stability Instructors in Leicestershire, Rutland or Derby City who were delivering a Local Authority-commissioned Falls Management Exercise program and were participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL)study.
- Able to provide written informed consent.
- Enrolled on a Local Authority Falls Management Exercise program in Derby City, Rutland or Leicestershire Counties and participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Able to provide written informed consent.
Key exclusion criteria (5 listed)
- Postural Stability Instructors delivering a falls prevention programme or Falls Management Exercise program that was not commissioned within Derby City, Rutland or Leicestershire Counties and not participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Unable to provide written informed consent
- KAPA participants
- Enrolled on a falls prevention programme or Falls Management Exercise program that was not commissioned within Derby City, Rutland or Leicestershire Counties and not participating in the PHysical activity Implementation Study In Community-dwelling AduLts (PHiSICAL) study.
- Unable to provide written informed consent.
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 |
|---|---|---|
| Keeping Adults Physically Active (KAPA) interventionThe Keeping Adults Physically Active (KAPA) intervention included six 60-90 minute group motivational interviewing sessions which were supported by a pedometer and a file containing information about locally run physical activity services, a home exercise booklet and written information on different types of lifestyle and transport related physical activity. During sessions the KAPA participants created physical activity plans and reflected on their physical activity diaries and personal physical activity goals. Various sub-sets of behaviour change techniques were delivered to help support the participants in continuing to be active. | Behavioural | KAPA intervention arm |
| Usual CareUsual care was delivered for the duration of the KAPA feasibility study. The usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package. Upon initiating the KAPA feasibility study it was unknown what the service provider would deliver as usual care. Therefore a study objective was to describe the usual care package delivered by the service providers. | Other | Usual care |
Primary outcome
Recruitment and retention rates in the intervention and control group
Time frame: 6 months
The researchers recorded the number of study sites, Postural Stability Instructors and KAPA participants invited and recruited into the feasibility study. Retention rates were recorded as the number of KAPA participants (i.e. intervention and usual care participants) who remained within the study and provided outcome data at the 6-month time point.
Attendance rates to the KAPA intervention sessions
Time frame: 6 months
The Postural Stability Instructors documented in the class registers the KAPA participants' attendance at each of the monthly telephone or face-to-face community based KAPA intervention sessions. Class registers were used to record the number of face to face and telephone interactions with the participants.
Assessing acceptability of the KAPA intervention: semi-structure interviews
Time frame: 12 months
Acceptability of the intervention was determined via semi-structure interviews with the participants in receipt of the intervention and the Postural Stability Instructors delivering the intervention, to assess the acceptability of the intervention features and delivery modes. Interview data was analysed using a framework analysis approach.
7 secondary outcomes
Training evaluation of the KAPA training day
Time frame: 1 day
Adherence to key KAPA intervention strategies
Time frame: 6 months
Fidelity of the KAPA interventions delivery
Time frame: 6 months
Parameter estimates of moderate to vigorous physical activity and Intra Class Coefficient
Time frame: 6 months
Defining usual care
Time frame: 6 months
Developing a cost proforma to cost KAPA for a definitive trial
Time frame: 9 months
The number of adverse events incurred in the KAPA intervention group.
Time frame: 6 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 31 Jan 2019.
- Derived from this study: PubMed 39360568Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.
- Derived from this study: PubMed 32161660Audsley S, Kendrick D, Logan P, Jones M, Orton E. A randomised feasibility study assessing an intervention to keep adults physically active after falls management exercise programmes end. Pilot Feasibility Stud. 2020 Mar 7;6:37. doi: 10.1186/s40814-020-00570-9. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth Orton principal investigator
University of Nottingham and NIHR
Questions about this trial
What is this clinical trial studying?
A study testing Keeping Adults Physically Active (KAPA) intervention in people with Physical Activity and Falls Prevention, run by University of Nottingham.
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 5 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Recruitment and retention rates in the intervention and control group (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824015, which also lists 2 linked publications.
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 31 Jan 2019.