Clinical trial NCT03824015: Keeping Adults Physically Active Feasibility Study
Official title: Keeping Adults Physically Active: Randomised Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Falls Prevention
Keywords: Physical Activity
Older Adults
Behaviour maintenance
feasibility study
falls prevention
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.

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:

1. Community dwelling Falls Management Exercise program service users aged 65 years or older (referred to as KAPA participants).
2. 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.

Eligibility criteria: Postural Stability Instructor participants

Inclusion criteria:

* 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.

Exclusion criteria:

* 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

Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Recruitment and retention rates in the intervention and control group
timeFrame: 6 months
measure: Attendance rates to the KAPA intervention sessions
timeFrame: 6 months
measure: Assessing acceptability of the KAPA intervention: semi-structure interviews
timeFrame: 12 months
Secondary outcomes:
measure: Training evaluation of the KAPA training day
timeFrame: 1 day
measure: Adherence to key KAPA intervention strategies
timeFrame: 6 months
measure: Fidelity of the KAPA interventions delivery
timeFrame: 6 months
measure: Parameter estimates of moderate to vigorous physical activity and Intra Class Coefficient
timeFrame: 6 months
measure: Defining usual care
timeFrame: 6 months
measure: Developing a cost proforma to cost KAPA for a definitive trial
timeFrame: 9 months
measure: The number of adverse events incurred in the KAPA intervention group.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham and NIHR
name: Elizabeth Orton
role: PRINCIPAL_INVESTIGATOR
References:
citation: Audsley 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.