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Clinical Trials/NCT05287932
NCT05287932CompletedNot Applicable

A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity

Northumbria University1 site in 1 country16 target enrollmentStarted: May 9, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Average daily acceleration

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessors will be blinded to group allocation, and participants will be asked to not disclose their allocation

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • aged ≥60 years
  • 2 or more chronic conditions
  • able to walk outside the home
  • able to attend the study visits

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Brief physical activity intervention (Behavioral)

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.

Outcomes

Primary Outcomes

Average daily acceleration

Time Frame: 4 weeks

Average acceleration from wrist accelerometry

Secondary Outcomes

  • Intensity gradient(4 weeks)
  • Time in MVPA(4 weeks)
  • Steps(4 weeks)
  • 30-second chair rise performance(4 weeks)
  • Timed 8ft up and go performance(4 weeks)
  • Timed single-leg balance performance(4 weeks)
  • Muscle strengthening exercise(4 weeks)
  • Handgrip strength(4 weeks)
  • 6-minute walk test performance(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Garry Tew

Professor Garry Tew

Northumbria University

Study Sites (1)

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