NCT03824015

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

January 14, 2019

Last Update Submit

January 29, 2019

Conditions

Keywords

Physical ActivityOlder AdultsBehaviour maintenancefeasibility studyfalls prevention

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12 months

Secondary Outcomes (7)

  • Training evaluation of the KAPA training day

    1 day

  • Adherence to key KAPA intervention strategies

    6 months

  • Fidelity of the KAPA interventions delivery

    6 months

  • Parameter estimates of moderate to vigorous physical activity and Intra Class Coefficient

    6 months

  • Defining usual care

    6 months

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

KAPA intervention arm

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.

Usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Elizabeth Orton

    University of Nottingham and NIHR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 31, 2019

Study Start

January 5, 2017

Primary Completion

April 22, 2018

Study Completion

April 22, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01