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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015078
Receipt No. R000017542
Scientific Title Combined intervention of exercise program with pain coping skills training among the elderly with knee pain: A randomized controlled study
Date of disclosure of the study information 2014/09/06
Last modified on 2014/09/06

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Basic information
Public title Combined intervention of exercise program with pain coping skills training among the elderly with knee pain: A randomized controlled study
Acronym Combined intervention of exercise and pain coping skills training among the elderly with knee pain
Scientific Title Combined intervention of exercise program with pain coping skills training among the elderly with knee pain: A randomized controlled study
Scientific Title:Acronym Combined intervention of exercise and pain coping skills training among the elderly with knee pain
Region
Japan

Condition
Condition Chronic knee pain
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of combined intervention of exercise program with pain coping skills training on knee pain and knee function among the elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measurements:
Pre-and post-intervention; 3-month and 9-month after the intervention

Outcomes:
1. Knee pain: Visual Analogue Scale (VAS)
2. Knee function: Western Ontario and McMaster Universities Osteoarthritis (WOMAC)
Key secondary outcomes Measurements:
Pre-and post-intervention; 3-month and 9-month after the intervention

Outcomes:
1. Exercise adherence: the number of intervention session attendance, frequency of strength training and stage of change for strength training behavior
2. Medical care seeking behavior: frequency of medical care seeking behavior for knee pain during last 3-month
3. Medication-taking behavior: use of medication for knee pain during last 3-month
4. Walking behavior: frequency of walking and walking time
5. Physical activity and sedentary behavior: Accelerometer (Active style Pro, OMRON)
6. Physical function: grip strength test, isometric knee extension strength test (hand held dynamometer), 5m walking time test, Timed Up & Go test, five-repetition sit-to-stand test, one-leg standing with opened eyes test
7. Psychological measures: Pain Self-efficacy Questionnaire, Coping Strategies Questionnaire, Pain Catastrophizing Scale, Hospital Anxiety and Depression scale, Brief fear of movement scale, Self-efficacy for strength training behavior
8. Health-related quality of life: SF-8, EQ-5D
9. Body composition: Body mass index (BMI), skeletal muscle mass

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 A 12-week combined exercise and pain coping skills training program (EX-PCS group) will be delivered on a group basis. Duration of this combined program is 90 minutes per session once a week. Total of 80 participants will be further divided into small groups (group size: 10-15) and implemented the program. Exercise consists of stretching and strength training. Pain coping skills training consists of practicing several techniques based on cognitive behavioral therapy. Moreover, printed materials (including self-monitoring sheet and textbook for exercise and pain coping skill) will be utilized for homework and home exercise.
Interventions/Control_2 A 12-week combined exercise and general health education for long-term care prevention will be delivered on a group basis for 90 minutes per session once a week as an active control (n=80). All methodology regarding exercise therapy is same as those in the EX-PCS group. Health education consists of major topics about a long-term care prevention (e.g. muscle strength, fall prevention, incontinence prevention, nutrition, oral health).
Interventions/Control_3 Control group (n=80) will be delivered the ready-made educational booklet about self-management of knee pain by postal mail and asked to be free to use it. Moreover, this control group will receive a postal mail to prevent the drop-out on the post-assessments once a month during 3-month intervention period.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Aged >= 65 years
2. Knee pain for >= 3 months
Key exclusion criteria 1. Averaged extremely mild knee pain within the last week: VAS<20
2. Averaged mild knee pain within the last week and high physical functions: 20<=VAS<30 and 5m-gait speed (male: <2.2sec, female: <2.4sec ) or TUG score (male: <5.0sec, female: <5.8sec )
3. Spine or lower limb surgery within the past 6 months
4. Awaiting or planning spine or lower limb surgery within the next 12 months
5. Current or past (within 3 months) oral or intra-articular corticosteroid use
6. Neurological condition such as Parkinsons disease, multiple sclerosis or stroke
7. Systematic arthritic conditions such as rheumatoid arthritis
8. Unstable angina, severe heart valve disease, congenital heart disease, decompensated heart failure, uncontrolled irregular pulse
9. Cancer pain
10. Cognitive impairment (MMSE<=19)
11. Psychiatric history such as schizophrenia
12. Consultation a doctor for rehabilitation (except for osteopathic clinic) within the past 6 months
13. Past participation in a PCST program
14. Inability to walk unaided as this is necessary for some of the physical assessment
15. Inadequate written and spoken Japanese
16. Unable to comply with the protocol such as inability to attend therapy sessions or attend assessment appointments at the university
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-6781
Email koka@waseda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-7189
Homepage URL
Email koka@waseda.jp

Sponsor
Institute Faculty of Sport Sciences, Waseda University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 09 Month 06 Day
Last modified on
2014 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017542

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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