UMIN-CTR Clinical Trial

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

Chronic knee pain

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Faculty of Sport Sciences, Waseda University

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

09

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

09

Month

06

Day

Last modified on

2014

Year

09

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017542