Brief Physical Activity Intervention for Older People With Multimorbidity

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

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 Overview

• Status: Completed
• Conditions: Old Age; Debility; Physical Inactivity; Chronic Conditions, Multiple
• Intervention / Treatment: Behavioral: Brief physical activity intervention

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle, United Kingdom
    • Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Brief physical activity intervention; See arm/group descriptions
No Intervention: Wait-list control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily acceleration	Average acceleration from wrist accelerometry	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity gradient	Intensity gradient from wrist accelerometry	4 weeks
Time in MVPA	Average daily time spent in moderate-to-vigorous physical activity from wrist accelerometry	4 weeks
Steps	Average daily step count	4 weeks
Muscle strengthening exercise	Average daily time spent doing muscle strengthening exercise	4 weeks
30-second chair rise performance	Number of sit-to-stand movements completed within 30 seconds	4 weeks
Handgrip strength	Maximum handgrip strength measured on both hands using a Jamar handgrip dynamometer	4 weeks
Timed 8ft up and go performance	Time to complete 8ft up and go test	4 weeks
Timed single-leg balance performance	Time able to stand on one limb	4 weeks
6-minute walk test performance	Total distance walked during 6-minute corridor walking test	4 weeks

Collaborators and Investigators

• Sponsor: Northumbria University
• Investigators: Principal Investigator: Garry A Tew, PhD, Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Physical activity; Older people; Multimorbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Frailty; Multiple Chronic Conditions
• Other Study ID Numbers: HLSGT030322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No