UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038591 |
|---|---|
| Receipt number | 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 | 2021/05/16 20:57:21 |
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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
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
koka@waseda.jp
Sponsor or person
Institute
Faculty of Sport Sciences, Waseda University
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 05 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043977
