search
Back to results

Brief Physical Activity Intervention for Older People With Multimorbidity

Primary Purpose

Chronic Conditions, Multiple, Old Age; Debility, Physical Inactivity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief physical activity intervention
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Conditions, Multiple focused on measuring Multimorbidity, Older people, Physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait-list control

Arm Description

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.

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 Outcome Measures

Average daily acceleration
Average acceleration from wrist accelerometry

Secondary Outcome Measures

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

Full Information

First Posted
March 10, 2022
Last Updated
September 26, 2022
Sponsor
Northumbria University
search

1. Study Identification

Unique Protocol Identification Number
NCT05287932
Brief Title
Brief Physical Activity Intervention for Older People With Multimorbidity
Official Title
A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Conditions, Multiple, Old Age; Debility, Physical Inactivity
Keywords
Multimorbidity, Older people, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot randomised controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to group allocation, and participants will be asked to not disclose their allocation
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief physical activity intervention
Intervention Description
See arm/group descriptions
Primary Outcome Measure Information:
Title
Average daily acceleration
Description
Average acceleration from wrist accelerometry
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Intensity gradient
Description
Intensity gradient from wrist accelerometry
Time Frame
4 weeks
Title
Time in MVPA
Description
Average daily time spent in moderate-to-vigorous physical activity from wrist accelerometry
Time Frame
4 weeks
Title
Steps
Description
Average daily step count
Time Frame
4 weeks
Title
Muscle strengthening exercise
Description
Average daily time spent doing muscle strengthening exercise
Time Frame
4 weeks
Title
30-second chair rise performance
Description
Number of sit-to-stand movements completed within 30 seconds
Time Frame
4 weeks
Title
Handgrip strength
Description
Maximum handgrip strength measured on both hands using a Jamar handgrip dynamometer
Time Frame
4 weeks
Title
Timed 8ft up and go performance
Description
Time to complete 8ft up and go test
Time Frame
4 weeks
Title
Timed single-leg balance performance
Description
Time able to stand on one limb
Time Frame
4 weeks
Title
6-minute walk test performance
Description
Total distance walked during 6-minute corridor walking test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garry A Tew, PhD
Organizational Affiliation
Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northumbria University
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.

Learn more about this trial

Brief Physical Activity Intervention for Older People With Multimorbidity

We'll reach out to this number within 24 hrs