Developing an Activity Pacing Framework: Feasibility and Acceptability

NCT03497585 | Completed Results

• 1 other identifier: IRAS:242203, V2.1, 27.04.18
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.

Conditions

Chronic Pain; Fibromyalgia; Chronic Fatigue Syndrome; Chronic Low Back Pain

Keywords

Rehabilitation; Pain Management

Outcome Measures

Primary Outcomes (1)

• Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme

  The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.

  Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme

Secondary Outcomes (27)

• Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)

  Baseline (pre-treatment: up to one week before the programme)

• Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)

  6-weeks (end of the programme)

• Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)

  3-months follow-up (after the end of the 6-week's programme)

• Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain

  Baseline (pre-treatment: up to one week before the programme)

• Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain

  6-weeks (end of the programme)

Study Arms (1)

Activity Pacing Framework

Adult patients attending rehabilitation programmes underpinned by the activity pacing framework.

Behavioral: Activity pacing framework

Interventions

Activity pacing framework BEHAVIORAL

The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.

Activity Pacing Framework

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals National Health Service (NHS) Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.

You may qualify if:

• Patients with an initial General Practitioner (GP)/hospital consultant referral to The Pennine Acute Hospitals NHS Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months.
• Patients referred to a rehabilitation programme for chronic pain/fatigue
• Patients aged ≥18 years
• Patients able to read/write in English

You may not qualify if:

• Patients with evidence of a serious underlying pathology, such as a current diagnosis of cancer
• Patients with severe mental health/cognitive functioning issues
• Patients with an initial GP/hospital consultant referral to The Pennine Acute Hospitals National Health Service (NHS) Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months (as per the feasibility study).
• Patients who attended a minimum of one session of the rehabilitation programme, who consented to the study and completed the first questionnaire booklet. Patients do not need to have completed the programme, since the interviews will include patients who both completed and did not complete the programme.
• Qualified healthcare professionals delivering the rehabilitation programmes who received training in using the activity pacing framework: physiotherapists and psychological wellbeing practitioners employed by The Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust.

Sponsors & Collaborators

• Pennine Acute Hospitals NHS Trust: lead
• University of Leeds: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

The Pennine Acute Hospitals NHS Trust

Bury, Lancashire, BL9 7TD, United Kingdom

Location

Related Publications (2)

• Antcliff D, Campbell M, Woby S, Keeley P. Activity Pacing is Associated With Better and Worse Symptoms for Patients With Long-term Conditions. Clin J Pain. 2017 Mar;33(3):205-214. doi: 10.1097/AJP.0000000000000401.

  PMID: 27322396 RESULT

• Antcliff D, Keenan AM, Keeley P, Woby S, McGowan L. Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study. BMJ Open. 2021 Dec 8;11(12):e045398. doi: 10.1136/bmjopen-2020-045398.

  PMID: 34880007 DERIVED

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Fatigue Syndrome, Chronic; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations

Limitations and Caveats

The target sample size of n=50 patients at 3-months follow-up (T3) for the feasibility study was attained (actual sample at T3: n=52). Despite recruiting to target for the feasibility study, this sample was not powered with a control arm to determine treatment effectiveness. The generalisability of this study is limited to a sample of predominantly females, of white ethnic origin and recruited from only one Pain Service in Northern England, United Kingdom (UK).

Results Point of Contact

• Title: Dr Deborah Antcliff
• Organization: Pennine Acute NHS Trust

Deborah.Antcliff@pat.nhs.uk

0161 7242168

Study Officials

• Deborah Antcliff, PhD, BSc

  Pennine Acute Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physiotherapist/Researcher

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 13, 2018
• Study Start: May 21, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)