NCT03961750

Brief Summary

The National Records of Scotland population projections show the pension age population increasing by 25% over the next 25 years. Falls are a major cause of hospitalisation in older adults, one in three community dwelling older adults over 65 years of age fall each year. There is a need to explore novel methods of delivering care to a growing older adult population. A programme of exercise called OTAGO has been found to reduce the number of falls for older adults. Several studies have explored the use of students to lead exercise interventions but these have not included assessing the impact to student educational experiences and outcomes with varying degrees of success on patient outcomes and no adverse events. Research Aim: To examine the feasibility of a student-led exercise intervention in improving falls risk outcomes for community dwelling older adults at risk of falling referred from NHS falls services. Study Design: A feasibility study examining a single patient group undertaking a 12 week, student-led, OTAGO exercise class for community dwelling older adults at Glasgow Caledonian University. OTAGO consists of progressive strength and balance exercises. Participants will be screened, invited to consent to the trial, asked to undertake the 12 week intervention and assessed using physical measures before and after the trial and face to face interviews after the trial. Recruitment will be through the NHS Greater Glasgow and Clyde and Lanarkshire community falls teams and the exercise delivery is consistent with usual care, the main difference is the location and student leaders. Students are qualified OTAGO Leaders. Funding has been received from AGILE the Chartered Society of Physiotherapists professional network working with older adults. Student educational experiences and outcomes will be assessed over the study period and are included in a separate study protocol

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

May 22, 2019

Last Update Submit

February 22, 2024

Conditions

Keywords

Older AdultOTAGOStudent led

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go

    Functional Outcome

    5-10 minutes to administer

Study Arms (1)

Intervention

EXPERIMENTAL

A feasibility study examining a single patient group undertaking a 12 week, student-led, OTAGO exercise class for community dwelling older adults at Glasgow Caledonian University. OTAGO consists of progressive strength and balance exercises.

Other: OTAGO

Interventions

OTAGOOTHER

12 Week exercise class programme

Also known as: Otago exercise classes
Intervention

Eligibility Criteria

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

You may qualify if:

  • Older adults - at least 65 years of age or older
  • Referred to the NHS falls service and identified as 'at risk of a fall' by the NHS falls team - this will be based on the discretion of the referring falls team. NB participants do not need to have experienced a fall to be included.
  • Community dwelling - participants need to be living independently, this can include a package of care or family support
  • Be able to ambulate independently with a walking aid (10 meters in a straight line)
  • have self-reported visual and auditory capacities to follow the exercises
  • have the capacity to provide a signed informed-consent statement based on the Six-item screener score with 2 or more wrong answers indicating a high risk of reduced capacity (Callahan et al, 2002, Carpenter et al, 2011).

You may not qualify if:

  • Participants -
  • living in a Residential or Care Home
  • unable to follow simple instructions or guidance
  • who have a medical contraindication for physical activity, participants will be asked to self-declare in line with the Health Commitment Statement (UKACTIVE,2018)
  • unable to ambulate independently 10 meters with a walking aid
  • with a severe visual and auditory disabilities
  • with an unstable cardiovascular disease
  • with a neurological disorder that could compromise them from exercising
  • with a lower-extremity fracture in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Caledonian University

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dawn Skelton, PhD

    Glasgow Caledonian University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pre Post test single cohort feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 23, 2019

Study Start

October 1, 2019

Primary Completion

October 27, 2021

Study Completion

September 1, 2023

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations