Brief Physical Activity Intervention for Older People With Multimorbidity

• Sponsor: Northumbria University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05287932
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.2
• Patients Per Site Per Month: 5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Conditions, Multiple; Old Age; Debility; Physical Inactivity	Behavioral: Brief physical activity intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pilot randomised controlled trialPilot randomised controlled trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors will be blinded to group allocation, and participants will be asked to not disclose their allocation
• Primary Purpose: Treatment
• Official Title: A Pilot Randomised Controlled Trial of a Brief Physical Activity Intervention in Older People With Multimorbidity
• Actual Study Start Date: May 9, 2022
• Anticipated Primary Completion Date: Aug 15, 2022
• Anticipated Study Completion Date: Aug 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Average daily acceleration [4 weeks]

   Average acceleration from wrist accelerometry

Secondary Outcome Measures

1. Intensity gradient [4 weeks]

   Intensity gradient from wrist accelerometry

2. Time in MVPA [4 weeks]

   Average daily time spent in moderate-to-vigorous physical activity from wrist accelerometry

3. Steps [4 weeks]

   Average daily step count

4. Muscle strengthening exercise [4 weeks]

   Average daily time spent doing muscle strengthening exercise

5. 30-second chair rise performance [4 weeks]

   Number of sit-to-stand movements completed within 30 seconds

6. Handgrip strength [4 weeks]

   Maximum handgrip strength measured on both hands using a Jamar handgrip dynamometer

7. Timed 8ft up and go performance [4 weeks]

   Time to complete 8ft up and go test

8. Timed single-leg balance performance [4 weeks]

   Time able to stand on one limb

9. 6-minute walk test performance [4 weeks]

   Total distance walked during 6-minute corridor walking test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northumbria University	Newcastle		United Kingdom

Sponsors and Collaborators

• Northumbria University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Garry Tew, Professor Garry Tew, Northumbria University
• ClinicalTrials.gov Identifier: NCT05287932
• Other Study ID Numbers: HLSGT030322
• First Posted: Mar 18, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Garry Tew, Professor Garry Tew, Northumbria University: Multimorbidity; Older people; Physical activity
• Additional relevant MeSH terms: Frailty; Multiple Chronic Conditions

Study Results

No Results Posted as of Aug 1, 2022