Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-02 @ 11:09 PM
Study NCT ID:
NCT02606318
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2015-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life
Sponsor:
Harue Hospital
Organization:
Study Overview
Official Title:
Adjusting Challenge-Skill Balance to Improve the Elderly's Quality of Life: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to clarify the effects on health-related QOL of occupational therapy involving the adjustment of challenge-skill balance in the activity of elderly clients.
Detailed Description:
This study was single-blind, randomized controlled trial. Clients were randomly assigned by blocked randomization (block size 4) to either the experimental group (occupational therapy that included assessment and adjustment of the challenge-skill balance of the activities) or to the control group (occupational therapy as normally conducted at the day care center). Randomization was stratified by sex and EuroQol visual analogue scale, resulting in four layers. The primary outcome was change in health-related quality of life after 10 sessions of occupational therapy. Clients were assessed before the intervention (pre-test) and after the 10th session (post-test). Significant differences were observed in the EuroQol-5 Dimension (EQ-5D) score and in the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) scores for general health, physical functioning , and vitality.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: