Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058886) titled 'Effects of Introducing an Activity Diary in Outpatient Pulmonary Rehabilitation on Activity Satisfaction and Sense of Meaning in Life: A Non-Randomized Controlled Trial' on Oct. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Hyogo Medical University
Condition:
Condition - Lung disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to clarify the effects of outpatient pulmonary rehabilitation combined with the use of an activity diary, which records daily activities and occupational experiences, on activity satisfaction, sense of meaning in life, self-efficacy, and health-related quality of life in patients with chronic respiratory diseases undergoing community-based pulmonary rehabilitation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention group will undergo standard outpatient pulmonary rehabilitation primarily consisting of exercise therapy (usual care) once or twice per week, in addition to the introduction of an activity diary, which they will be asked to complete daily for three months. If patients are unable to maintain diary entries independently during the intervention period or require assistance, they will complete the diary with support from an occupational therapist during outpatient pulmonary rehabilitation. Based on the recorded diaries, patients will review their activities with the occupational therapist on a weekly basis. The activity diary will include the most meaningful activity of the day and its related experience, the level of satisfaction with the activity, and goals for the following day (or week). Each diary entry will take approximately five minutes to complete.
Interventions/Control_2 - The control group will receive standard outpatient pulmonary rehabilitation primarily consisting of exercise therapy (usual care).
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - Patients who have been undergoing outpatient pulmonary rehabilitation at our institution for at least three months and whose condition is clinically stable.
Key exclusion criteria - Patients diagnosed with dementia or suspected dementia who have difficulty completing or reviewing the diary.
Patients who do not provide informed consent to participate in the study.
Target Size - 58
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2027 Year 03 Month 10 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067269
Disclaimer: Curated by HT Syndication.