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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038591
Receipt No. R000043977
Scientific Title The effects of Acceptance and Commitment Therapy among older outpatients with knee pain: A randomized controlled trial
Date of disclosure of the study information 2019/11/15
Last modified on 2020/03/23

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Basic information
Public title The effects of Acceptance and Commitment Therapy among older outpatients with knee pain: A randomized controlled trial
Acronym The effects of Acceptance and Commitment Therapy among older outpatients with knee pain
Scientific Title The effects of Acceptance and Commitment Therapy among older outpatients with knee pain: A randomized controlled trial
Scientific Title:Acronym The effects of Acceptance and Commitment Therapy among older outpatients 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 Acceptance and Commitment Therapy with exercise therapy on knee pain among the older outpatients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Measurements:
1-month before the intervention; pre-and post-intervention; 1-month after the intervention

Outcome:
Japanese Knee Osteoarthritis Measure (JKOM)
Key secondary outcomes Measurements:
1-month before the intervention; pre-and post-intervention; 1-month after the intervention

Outcomes:
1.Psychological inflexibility toward pain: Psychological Inflexibility in Pain Scale (PIPS)
2.Anixiety and Depression: Hospital Anxiety and Depression Score (HADS)
3.Leg strength: Five-Times Sit-to-Stand Test (FTSS)
4.Physical activity and sedentary behavior: Accelerometer (Active style Pro, OMRON)

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 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 The Acceptance and Commitment Therapy (ACT) group participate in an hour intervention per session, one a week, for 8 weeks. This intervention provides 30 minutes each of ACT and exercise therapy. ACT consists of eight programs with the aim of increasing psychological flexibility as a treatment process. Further, printed materials are utilized for homework and home exercise. The exercise therapy consists of lower limb strength training.
Interventions/Control_2 The exercise therapy group is delivered a 30-minute individual intervention, one a week, for 8 weeks. This intervention provides lower limb strength training as in the ACT group.
Interventions/Control_3
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.Diagnosis of knee osteoarthritis
3.Knee pain for >= 1 month
4.Moerate or higher knee pain (Visual Analog Scale >= 30)
Key exclusion criteria 1.Cognitive decline that cannot be answered in the questionnaire
2.Outdoor walking is not independent
3.Experience cognitive behavioral therapy within the past 3 months
4.Knee surgery within the past 3 months
5.Knee surgery within the next 3 months
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima Tokorozawa, Saitama
TEL 04-2947-7189
Email koka@waseda.jp

Public contact
Name of contact person
1st name Koichiro
Middle name
Last name Oka
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
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 Faculty of Sport Sciences, Waseda University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Sport Sciences, Waseda University
Address 2-579-15 Mikajima Tokorozawa, Saitama
Tel 04-2947-7189
Email koka@waseda.jp

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 長谷川病院 (千葉県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 15 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
2019 Year 10 Month 15 Day
Date of IRB
2019 Year 11 Month 15 Day
Anticipated trial start date
2019 Year 12 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 15 Day
Last modified on
2020 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043977

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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