NCT05287932

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

March 10, 2022

Last Update Submit

September 26, 2022

Conditions

Keywords

MultimorbidityOlder peoplePhysical activity

Outcome Measures

Primary Outcomes (1)

  • Average daily acceleration

    Average acceleration from wrist accelerometry

    4 weeks

Secondary Outcomes (9)

  • Intensity gradient

    4 weeks

  • Time in MVPA

    4 weeks

  • Steps

    4 weeks

  • Muscle strengthening exercise

    4 weeks

  • 30-second chair rise performance

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

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.

Behavioral: Brief physical activity intervention

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.

Interventions

See arm/group descriptions

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle, United Kingdom

Location

MeSH Terms

Conditions

Multiple Chronic ConditionsFrailtySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Garry A Tew, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group allocation, and participants will be asked to not disclose their allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pilot randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Garry Tew

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

May 9, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

External requests for this data will be considered by the Chief Investigator after the publication of the main trial findings.

Locations