Cognitive DeclineNCT02114125
Effects of the Physical Activity and Cognitive Training Program
A study testing Physical Activity and Cognitive Training in people with Cognitive Decline, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Physical Activity and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 year and older
- Able to communicate verbally
- Able to discern 5*5 cm2 picture from a viewing distance of 20 cm
- Able to hear a sound of normal speech from a distance of 20 cm
- Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort
- Has cognitive decline status assessing by CASI 2.0
- Lived in long-term care facilities during the study
Who cannot join
- Complete aphasia, blindness, deafness or completely dependent
- Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression
- Thrombophlebitis, or malignancy of the limbs.
- Refusal by patient or family member.
- Others. Reason to be well documented.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Unversity Hospital
Taipei, Taiwan, 100
Meei-Fang Lou, PhD, 886-2-23123456 ext. 88441, mfalou@ntu.edu.tw
Chien-Ning Tseng, PhC, 886-2-23123456 ext. 88441, kabyjean@gmial.com
About this study
Official title: The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities.
The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.
Read the detailed description
- to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
- to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.
- Conditions
- Cognitive Decline
- Being tested
- Physical Activity, Cognitive Training
- Keywords
- Physical activity, Cognitive training
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
group-based physical activity
Cognitive TrainingBehavioural
individual-based, multi-domains cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group: | No intervention | Usual care consists of standard institutionalized services provided by physicians, nurses, and support staff (e.g., nurse assistants, social workers) in long-term care facilities. |
| High-intensity physical activity (5PA) | Experimental | The intervention conducts the group-based physical activity, 5 days per- week for 8 weeks. Receives: Behavioral: Physical Activity |
| Low-intensity PA and CT(3PA+2CT) | Experimental | The intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks. Receives: Behavioral: Physical Activity; Behavioral: Cognitive Training |
| High-intensity PA and CT (5PA+5CT) | Experimental | The intervention conducts the individual-based, multi-domains cognitive training, 5days per- week and group-based physical activity, 5 days per- week and for 8 weeks. Receives: Behavioral: Physical Activity; Behavioral: Cognitive Training |
| Low-intensity cognitive training (2CT) | Experimental | The intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks. Receives: Behavioral: Cognitive Training |
| High-intensity cognitive training (5CT) | Experimental | The intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks. Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cognitive Function at 8 weeks and 16weeks
Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version
Measured: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Secondary outcomes (2)
Change from Baseline Depression at 8 weeks and 16weeks
Depression: Geriatric depression scale (GDS)-15 in Chinese version.
Measured: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
Quality of Life: Short Form-12 (SF-12) in Chinese version.
Measured: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Meei-Fang Lou, PhD, Principal investigator, Department of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114125
- Sponsor's protocol ID
- 201112011RID
- Status last verified
- Apr 2014
- First submitted
- 2 Nov 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Activity and Cognitive Training in Improving Cognitive Function of Institutionalized Older Residents
- ClinicalTrials.gov ID
- NCT02114125
- Acronym / sponsor ID
- 201112011RID
- Conditions
- Cognitive Decline
- Keywords
- Physical activity, Cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators assume that there are some positive effects of cognitive training and physical activities on cognitive function, depression and quality of life in a sample of older residents in long-term care facilities.
The purpose of this study is to explore the effects of various interventions (physical activity, cognitive training, integration of physical activity and cognitive training) on different outcome indictors in institutionalized older residents.
Detailed description
- to develop an intervention protocol that achieves clinical development objectives in a scientifically rigorous and time efficient manner.
- to further analyze the effects of the various interventions and make a comparison of dose-response relation and efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group: | No intervention | –Usual care consists of standard institutionalized services provided by physicians, nurses, and support staff (e.g., nurse assistants, social workers) in long-term care facilities. |
| High-intensity physical activity (5PA) | Experimental | Behavioral: Physical ActivityThe intervention conducts the group-based physical activity, 5 days per- week for 8 weeks. |
| Low-intensity PA and CT(3PA+2CT) | Experimental | Behavioral: Physical Activity, Behavioral: Cognitive TrainingThe intervention conducts 3 days per-week physical activity and 2 days per-week cognitive training for 8 weeks. |
| High-intensity PA and CT (5PA+5CT) | Experimental | Behavioral: Physical Activity, Behavioral: Cognitive TrainingThe intervention conducts the individual-based, multi-domains cognitive training, 5days per- week and group-based physical activity, 5 days per- week and for 8 weeks. |
| Low-intensity cognitive training (2CT) | Experimental | Behavioral: Cognitive TrainingThe intervention conducts the individual-based, multi-domains cognitive training, 2 days per- week for 8 weeks. |
| High-intensity cognitive training (5CT) | Experimental | Behavioral: Cognitive TrainingThe intervention conducts the individual-based, multi-domains cognitive training, 5 days per- week for 8 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 year and older
- Able to communicate verbally
- Able to discern 5*5 cm2 picture from a viewing distance of 20 cm
- Able to hear a sound of normal speech from a distance of 20 cm
- Able to sit in a chair or wheelchair independently for more than 30 minutes without changes in vital signs and awareness and without physical discomfort
Key exclusion criteria (5 listed)
- Complete aphasia, blindness, deafness or completely dependent
- Unstable angina, arrythmia, myocardial infarction history, postural hypotension, transient cerebral hypoxia or other psychiatric disorders except depression
- Thrombophlebitis, or malignancy of the limbs.
- Refusal by patient or family member.
- Others. Reason to be well documented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activitygroup-based physical activity | Behavioural | High-intensity PA and CT (5PA+5CT), High-intensity physical activity (5PA), Low-intensity PA and CT(3PA+2CT) |
| Cognitive Trainingindividual-based, multi-domains cognitive training | Behavioural | High-intensity PA and CT (5PA+5CT), High-intensity cognitive training (5CT), Low-intensity PA and CT(3PA+2CT), Low-intensity cognitive training (2CT) |
Primary outcome
Change from Baseline Cognitive Function at 8 weeks and 16weeks
Time frame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Cognitive Function: Cognitive Assessment Screening Instrument (CASI) 2.0 in Chinese version
2 secondary outcomes
Change from Baseline Depression at 8 weeks and 16weeks
Time frame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Change from Baseline Quality of Life at 8 weeks and 16weeksStatus:
Time frame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meei-Fang Lou, PhD principal investigator
Department of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Cognitive Training in people with Cognitive Decline, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meei-Fang Lou, PhD (886-2-23123456 ext. 88441, mfalou@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cognitive Function at 8 weeks and 16weeks (time frame: pre-treatment (0 week, T0), post-treatment (8 weeks, T1) and follow-up (16 weeks, T2 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.