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Patient Adherence to a Physical Activity Advice (PAPA)

This study is currently recruiting participants.
Verified December 2016 by Ben van Koppen, Maastricht University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02996955
First Posted: December 19, 2016
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ben van Koppen, Maastricht University
  Purpose

Rationale: Low back pain is worldwide a common musculoskeletal condition with a high number of recurrences. Recurrence rate and the number of recurrences could be reduced and time to a next episode could be prolonged by advising an active lifestyle. Advising regular physical activity is the mainstay in physical therapy treatment. This includes an appeal to patients to adhere to an activity advice. Patient adherence to an activity advice is poor. Many factors influence adherence. In this study an intervention consisting of treatment of illness perceptions with or without organizing social support to increase adherence to an activity advice will be investigated.

Objective: The primary objective of this study is to investigate whether social support by a partner or friend and treatment of patients' illness perceptions influences the rate of adherence to an activity advice compared to treatment of patients' illness perceptions alone in patients suffering non-specific low back pain. Secondary objectives are; a) whether 'treatment of illness perceptions' changes patients' maladaptive illness perceptions into realistic ones, b) whether maladaptive illness perceptions, comorbidity and/or overweighed/obesity and/or rate of recurrences of non-specific low back pain and/or attitude and intention to physical activity influences patient's adherence to an activity advice.

Study design: This study is a multi-centre randomized two-arm controlled clinical trial.

Study population: Patients ≥18 years presenting with at least a second episode of non-specific low back pain.

Intervention: Patients in the intervention and control group will be asked to perform a physical activity advice. During two physiotherapy treatment sessions treatment of illness perceptions is performed in both groups. In the intervention group organizing social support by a partner or friend is added.

Main study parameters/endpoints: Twenty-five percent absolute improvement of walking and/or cycling according the NNGB in the intervention group is clinically relevant.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During four appointments several questionnaires have to be filled in and during two physiotherapy treatment sessions half an hour treatment of illness perceptions will be performed. Social support by a partner or friend will be organized during the same physiotherapy treatment sessions in the intervention group. During three separate weeks patients have to wear an activity monitor. Patients will be treated according to the Dutch Low Back Pain guideline; no adverse effects will be expected.


Condition Intervention
Patient Adherence Behavioral: social support Behavioral: treatment of illness perceptions Device: Activ8 Other: activity advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Social Support and Treatment of Illness Perceptions on Patient's Adherence to a Physical Activity Advice

Further study details as provided by Ben van Koppen, Maastricht University:

Primary Outcome Measures:
  • adherence to the activity advice [ Time Frame: 12 weeks ]
    proportion of patients (non)adhering to the activity advice measured by the Activ8


Secondary Outcome Measures:
  • changes in patient's illness perceptions [ Time Frame: base line, one week, 6 and 12 weeks ]
    proportion of patients with (un)changed illness perceptions measured by the Brief Illness Perception Questionnaire- short, Dutch version.


Other Outcome Measures:
  • influence of illness perception on adherence [ Time Frame: 12 weeks ]
    proportion of patients with (mal)adaptive illness perception measured by the BIPQ-s Dutch version (non)adhering the activity advice measured by the Activ8

  • influence of comorbidity on adherence [ Time Frame: 12 weeks ]
    proportion of patients with or without comorbidity measured by the Cumulative Illness Rating Scale (non)adhering the activity advice measured by the Activ8

  • influence of overweight/obesity on adherence [ Time Frame: 12 weeks ]
    proportion of patients with or without overweight/obesity measured with Body Mass Index (non)adhering the activity advice measured by the Activ8

  • influence of number of episodes of low back pain on adherence [ Time Frame: 12 weeks ]
    proportion of patients with or without more than 2 episodes low back pain (non)adhering the activity advice measured by the activ8

  • change of influence of attitude and intention to a physical activity on adherence [ Time Frame: base line, one week, 6 and 12 weeks ]
    proportion of patients with or without adequate atitude/intention to physical activity measured by the Module Houding en Intentie Questionnaire (non)adhering the activity advice measured by the Activ8


Estimated Enrollment: 240
Study Start Date: November 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SoSup group
usual care will be provided and social support and treatment of illness perceptions and activity advice and wearing the activ8
Behavioral: social support
behaviour change intervention
Behavioral: treatment of illness perceptions
educational interview
Device: Activ8
wearing a move monitor
Other: activity advice
walking or cycling 5 days a week during at least half an hour
Active Comparator: C group
usual care will be provided and treatment of illness perceptions and activity advice and wearing the Activ8
Behavioral: treatment of illness perceptions
educational interview
Device: Activ8
wearing a move monitor
Other: activity advice
walking or cycling 5 days a week during at least half an hour

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• Non-specific low back pain

Exclusion Criteria:

  • Patients physical active in accordance with the Dutch Standard Healthy Physical Activity (NNGB) (Hildebrandt et al., 2007)
  • Patients with specific low back pain
  • Onset of the low back pain after age 50 years,
  • Continuous pain regardless of posture or movement,
  • Nocturnal pain,
  • General malaise,
  • History of malignancy,
  • Unexplained weight loss,
  • Elevated erythrocyte sedimentation rate (ESR)
  • Previous vertebral fracture,
  • Older person with hip fracture,
  • Prolonged use of corticosteroids,
  • Onset of low back pain before age 20 years,
  • Iridocyclitis,
  • History of unexplained peripheral arthritis or inflammatory bowel disease,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996955


Contacts
Contact: Ben van Koppen 0031102937111 ben.van.koppen.mmt@gmail.com
Contact: Pim Zandwijk 0031786428848 pzandwijk@kpnplanet.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6200MD
Sponsors and Collaborators
Maastricht University
Investigators
Study Chair: Rob de Bie, Prof. PhD Maastricht University
Study Chair: Henk van Mameren, Em Prof PhD Maastricht University
  More Information

Responsible Party: Ben van Koppen, Principal Investigator, Maastricht University
ClinicalTrials.gov Identifier: NCT02996955     History of Changes
Other Study ID Numbers: NL58005.096.16
First Submitted: November 29, 2016
First Posted: December 19, 2016
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ben van Koppen, Maastricht University:
Low Back Pain
Social Support
Illness Perceptions
Activity Advice


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