Effects of Adapted Snacktivity™ Intervention on Cognition and Self-Care in COPD Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe University of Hong Kong
About this trial
This clinical trial aims to evaluate whether a culturally adapted Snacktivity™ program can improve cognitive function and self-care abilities in patients with Chronic Obstructive Pulmonary Disease (COPD) in Hong Kong.
The main questions it aims to answer are:
1. Does the Snacktivity™ program improve the cognitive function of participants (including both global cognition and targeted subdomains)? 2. Does the program improve participants' self-care abilities?
The study consists of three sequential phases:
Phase 1 (Co-design workshops): Co-design workshops will be conducted with COPD patients, healthcare professionals (nurses, physical therapists, occupational therapists), and family caregivers to culturally adapt the Snacktivity™ program for Hong Kong COPD patients.
Phase 2 (Feasibility Pilot RCT): The adapted program will be tested in a small-scale pilot study to assess its feasibility and short-term clinical effects.
Phase 3 (Full-scale RCT): A full-scale randomised controlled trial will be conducted to evaluate the program's efficacy on the primary and secondary outcomes.
Participants in the intervention group will be asked to:
Participate in the culturally adapted Snacktivity™ program that integrates short, manageable "snacks" of physical activity into daily routines.
Wear an activity tracker to monitor physical activity levels. Complete questionnaires at multiple time points assessing cognitive function, self-care abilities, physical activity levels, self-efficacy, exercise capacity, quality of life, anxiety, and depression.
Researchers will compare the intervention group to an attention control group (receiving usual care with health education) to see if the Snacktivity™ program leads to greater improvements in these outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of COPD in accordance with the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline, with a post-bronchodilator ratio of FEV₁/FVC < 70%;
Aged ≥ 60 years;
Clinically stable condition;
Score at or below the age- and education-adjusted cutoff (16th percentile) on the Hong Kong Montreal Cognitive Assessment (HK-MoCA) 5-minute Protocol, indicating mild cognitive impairment;
Disqualifiers
Receipt of oxygen therapy for ≥ 15 hours per day or requirement for mechanical ventilation;
History of brain injury or stroke;
Presence of severe comorbidities including coronary artery disease, severe hepatic or renal dysfunction;
Diagnosis of psychiatric disorders, deafness, severely limited physical mobility, or inability to cooperate with trial interventions;
Trial design
Design model
Parallel
Treatments tested in this trial
Snacktivity™ Intervention
BehavioralParticipants in this arm receive the culturally adapted Snacktivity™ program. The intervention integrates short, manageable "snacks" of moderate-intensity physical activity (2-5 minutes per session, 5-6 sessions per day) into daily routines to accumulate at least 150 minutes of physical activity per week. Participants wear a Garmin activity tracker to objectively monitor physical activity levels. The intervention lasts 12 weeks and includes a 30-minute pre-intervention guidance session, a self-guided manual with illustrated activity templates, and structured follow-up support consisting of one weekly 30-minute in-depth session and two weekly 10-15-minute brief sessions. During each follow-up session, researchers recommend specific activity templates based on the participant's reported daily routine and co-develop a personalized 2-3 day activity schedule, which is documented in the participant's training manual.
attention control
BehavioralParticipants in this arm receive usual care plus additional attention to control for the non-specific effects of time and contact. They attend a single 60-minute group health education session on general lifestyle modification, based on the Hospital Authority's "COPD Self-Management Guide" (3rd Edition), with no physical activity advice or recommendations provided. During the 12-week intervention period, they receive the same two-tier follow-up schedule as the intervention group (one weekly 30-minute session and two weekly 10-15-minute brief sessions), focusing on general lifestyle assessment (e.g., sleep quality, nutrition, mood) and encouragement to maintain healthy behaviors, without any physical activity planning or template selection.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Snacktivity™ Intervention GroupExperimental treatment 1 intervention
Group B: Attention Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Global cognition
Global cognition will be assessed using the HK-MoCA. Developed originally by Dr. Ziad S. Nasreddine, the HK-MoCA is a validated and sensitive tool for global cognitive screening, which is specifically adapted to evaluate the cognitive status of patients in the Hong Kong region.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)2
Memory
We employed the Huashan version of the Auditory Verbal Learning Test (AVLT) adapted by Guo et al., to assess participants' memory. The test materials consist of three categories of nouns (clothing, occupations, and flowers), each with four related words, for a total of 12 target words. The test procedures and scoring methods are as follows: First, an immediate recall task is conducted. Participants are required to recall the 12 target words immediately after the tester reads them aloud, and this process is repeate times. The total score of immediate recall is the sum of the number of correctly recalled words in the three consecutive tests, with a maximum score of 36. Subsequently, delayed recall tasks are performed after 5 minutes (short-term delayed recall) and 20 minutes (long-term delayed recall), requiring participants to recall the target words. Meanwhile, a cued recall task is added, which requires participants to recall the words by category. The individual total scores for
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)3
Language
The Animal Fluency Test (AFT) is used to assess the language function of the participants. The specific requirements are: the participants need to name as many different animals as possible within 1 minute, and the number of animals listed is used as the evaluation indicator. The results are judged based on the educational level: for those with junior high school education or below, if the number is less than 12; for those with high school education, if the number is less than 12; for those with college education or above, if the number is less than 14, all of which are judged as abnormal results. The lower the score of this test, the worse the language function of the participant.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)4
Executive function
The Shape Trails Test (STT), a subtest of the Halstead-Reitan Neuropsychological Test Battery, is used to assess the executive function of participants.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)Secondary outcomes
1
Physical Activity Levels
Physical activity levels will be assessed using the Chinese version of the Physical Activity Scale for the Elderly (PASE-C), which measures leisure time, household, and work-related physical activities over the past 7 days.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)2
Self-Efficacy
Self-efficacy will be assessed using the Chinese version of the Exercise Self-Regulatory Efficacy Scale (Ex-SRES-Chinese), a 16-item scale measuring participants' confidence in adhering to exercise. Total scores range from 0 to 160, with higher scores indicating higher exercise self-efficacy.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)3
Exercise Capacity
Exercise capacity will be assessed using the 6-minute walk test (6MWT), conducted in accordance with American Thoracic Society guidelines. The distance walked in 6 minutes (6MWD) will be recorded.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)4
Health-Related Quality of Life
Health-related quality of life will be assessed using the COPD Assessment Test (CAT), an 8-item questionnaire. Total scores range from 0 to 40, with higher scores indicating poorer quality of life.
Time frame
Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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