Effect Study of on Intervention on Pain, Function, Health and Behaviour for Older Adults Living With Chronic Pain
NCT ID: NCT02953470
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2016-10-31
2018-09-30
Brief Summary
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The study is a pragmatic randomized controlled trial with one intervention group and one control group. The intervention is a 12-weeks home-based program. The intervention consists of an individually tailored intervention and aims to enhance ability to perform everyday activities by improving physical function and reduce pain-related beliefs and pain-related disability. The comparison group achieves general advice about physical activity. All participants will be tested at baseline, a post-assessment at 12 week and a three month follow-up. Primary outcome is pain interference by the Brief Pain Inventory and physical function by Short Physical Performance Battery.
Secondary outcomes measures if the goal setting is reached, self-efficacy in relation to the goal setting, pain catastrophizing, level of physical Activity, falls efficacy and Health related quality of life.
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Detailed Description
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The base for the intervention is to identify a problematic everyday activity and identify factors, including physical, psychological and environmental factors, that can inhibit and/or promote the ability to perform the activity. The exercise that will improve the physical factors will be based on functional exercise such as Balance training and muscle strength training, e.g. fast walking in circle, marching on the spot with a high knee lift, leg lifts, power walking and stair walking, squats, lunge, turning trunk and head while standing, and walking over obstacles. Number of exercises and the dosage are based on how much the participant are able to do and want to do and will increase progressively considering the changes in function and health status of the participants. The content of the visits is as follow:
Session: Identification of a problematic everyday activity and advice about physical activity.
Session 2: Doing functional behavioural analyse including goal setting, discuss performance dosage of training.
Session 3-5: Training in the basic physical and psychological skills relevant to goal setting.
Session 6-9: Training to apply basic skills adequately for the goal setting, application of basic and applied skills to other behaviours, starting with subsequent activity goals.
Discussion about how the participant can be able to maintain their new behaviour.
Discussion of problem-solving strategies, how he/she can prevent and address new activity problems that may arise related to the goal setting and in relation to being physically active.
During the intervention period will the participant receive visits by a physiotherapist during intervention weeks 1-8 and 12. Under week 10 will the participants receive one telephone call for support.
Non-intervention Group
The comparison group will receive standard care which means that the participants get one visit from physiotherapist which consist of written and oral information about general advice regarding physical Activity..Further will the comparison group receive telephone Calls to remind them of being physically active according to the advice during week 1-8 and week 10.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Individual tailored functional exercise
Receives general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. The intervention group, which is based on a behavioural medicine approach in physiotherapy, also receive individual tailored functional exercise with the goal to enhance the ability to perform everyday activities by reduce pain-related disability and pain-related beliefs and increase physical function. The participants receive 9 visits from a physiotherapist during the 12 weeks period. The participants will also fill in a activity diary to check the compliance to the intervention and to enhance their self-efficacy in relation to perform everyday activities, exercise and physical activity.
Individual tailored functional exercise
Receive individual tailored exercise to increase ability to perform everyday activities through increased physical function and self-efficacy in relation to be able to exercise and decreased pain-related beliefs such as fear of falling, catastrophizing thoughts and fear of movement.
Standard care
The participants in the comparison Group will receive standard care which means that they receives one visit from physiotherapist where the participant receive general advice about physical activity with the goal to be physically active at least 30 minutes per day at 5 of 7 days per week. During intervention week 1-8 and 10 the participants receive telephone calls once a week where they will be reminded to follow the advice about physical activity.
Standard care
Receives written and oral advice about physical Activity and the benefits of being physically active by one visits from a physiotherapist. Than will the participants receive Telephone reminder about following the advice once a week during intervention week 1-8 and 10.
Interventions
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Individual tailored functional exercise
Receive individual tailored exercise to increase ability to perform everyday activities through increased physical function and self-efficacy in relation to be able to exercise and decreased pain-related beliefs such as fear of falling, catastrophizing thoughts and fear of movement.
Standard care
Receives written and oral advice about physical Activity and the benefits of being physically active by one visits from a physiotherapist. Than will the participants receive Telephone reminder about following the advice once a week during intervention week 1-8 and 10.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
75 Years
ALL
No
Sponsors
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Oslo Metropolitan University
OTHER
Responsible Party
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Principal Investigators
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Astrid Bergland, Professor
Role: STUDY_CHAIR
Oslo Metropolitan University
Locations
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Sara Cederbom
Oslo, , Norway
Countries
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References
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Cederbom, S. (2014). Ability in everyday activities and morale among older women with chronic musculoskeletal pain living alone. A behavioural medicine approach in physiotherapy (Doctoral Thesis), Karolinska Institutet, Stockholm,Sweden
AGS Panel on Persistent Pain in Older Persons. The management of persistent pain in older persons. J Am Geriatr Soc. 2002 Jun;50(6 Suppl):S205-24. doi: 10.1046/j.1532-5415.50.6s.1.x. No abstract available.
Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/
Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Klepstad P, Loge JH, Borchgrevink PC, Mendoza TR, Cleeland CS, Kaasa S. The Norwegian brief pain inventory questionnaire: translation and validation in cancer pain patients. J Pain Symptom Manage. 2002 Nov;24(5):517-25. doi: 10.1016/s0885-3924(02)00526-2.
Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.
Helbostad JL, Taraldsen K, Granbo R, Yardley L, Todd CJ, Sletvold O. Validation of the Falls Efficacy Scale-International in fall-prone older persons. Age Ageing. 2010 Mar;39(2):259. doi: 10.1093/ageing/afp224. Epub 2009 Dec 22. No abstract available.
Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Med Sci Sports Exerc. 2007 Aug;39(8):1435-45. doi: 10.1249/mss.0b013e3180616aa2.
Jakobsson U, Westergren A, Lindskov S, Hagell P. Construct validity of the SF-12 in three different samples. J Eval Clin Pract. 2012 Jun;18(3):560-6. doi: 10.1111/j.1365-2753.2010.01623.x. Epub 2011 Jan 6.
Frändin K, Grimby G. Assessment of physical activity, fitness and performance in 76-year-olds. Scand J Med Sci Sports. 1994;4(1):41-6.
Utne I, Miaskowski C, Bjordal K, Paul SM, Jakobsen G, Rustoen T. Differences in the use of pain coping strategies between oncology inpatients with mild vs. moderate to severe pain. J Pain Symptom Manage. 2009 Nov;38(5):717-26. doi: 10.1016/j.jpainsymman.2009.03.005. Epub 2009 Sep 22.
Other Identifiers
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OsloAUCAS2016/859
Identifier Type: -
Identifier Source: org_study_id
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