Cognitive ChangeLIVESNCT05631106
Lifestyle Interventions for Vitality and Empowerment in Seniors
A study testing High Intensity Interval Resistance Training and Stretching, Balance, and Range of motion in people with Cognitive Change, run by Wake Forest University.
Trial summary
The goal of this clinical trial is to test a newer type of high intensity interval resistance training in adults 65 years of age or older. The main aims of this study are: 1. To develop study procedures in order to conduct a randomized controlled trial to test the impact of high intensity interval training on… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- High Intensity Interval Resistance Training and Stretching, Balance, and Range of motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2023
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Lives within 20 miles of the school
- Does not plan to travel outside the home geographic area for an extended period during the study participation
- Willing to provide informed consent
- Willing to be randomized to either lifestyle intervention group
- Willing to complete all study procedures and assessments
- No contraindications to exercise
- Capacity to complete physical exercise
Who cannot join
- Dependent on walking device
- Claustrophobia
- Performs 30 minutes of moderate intensity exercise three times per week for the previous three months
- Joint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-months
- Uncontrolled hypertension
- Pathological neurological condition
Show all 27Show fewer
- Parkinson's disease
- Unstable depression, anxiety, or schizophrenia (medication changes in the past 6 months)
- Experienced a concussion within the last 6 months
- Respiratory disease requiring oxygen
- Cancer requiring treatment
- Osteoarthritis
- Osteopenia or Osteoporosis
- Body mass index under 18
- Muscle wasting disease
- Hypertrophic or dilated cardiomyopathy significant cardiovascular disease (NIHA Class III/IV congestive heart failure, aortic stenosis, history of cardiac arrest, uncontrolled angina)
- Currently receiving physical therapy or cardiopulmonary rehabilitation
- Type I or insulin dependent Type II Diabetes
- Any implanted medical devices that are not compatible with fMRI scans (cardiac pacemaker or implanted cardiac defibrillator (ICD))
- Metal shavings in eyes
- Ferromagnetic piercings that cannot be taken out
- Transdermal patches that cannot be removed
- Cerebral aneurysm clip
- >14 alcoholic drinks in one week
- Not receiving medical clearance after PARQ+
- Evidence of cognitive impairment (Scoring below 32 points on the Telephone Interview of Cognitive Status)
- Site PI/Study Clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence, clinical judgement
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this clinical trial is to test a newer type of high intensity interval resistance training in adults 65 years of age or older. The main aims of this study are:
- To develop study procedures in order to conduct a randomized controlled trial to test the impact of high intensity interval training on cognition in older adults. We will develop procedures for recruitment, screening, data collection, blinded randomization, HIIRT and EA interventions, safety monitoring, and data analyses.
- To determine the feasibility of using high intensity interval resistance training as an intervention. Feasibility will be shown by; 1) recruiting the target population and meeting our overall patient accrual goal of 30 participants over a 12-week period, 2) achieving an average attendance rate of ≥ 70% of the 24 scheduled sessions in the HIIRT group, 3) at least 80% retention of participants at the final follow-up assessment (week 12), and 4) successful completion of the MRI task (finishing the session with a behavioral accuracy greater than 70%) by at least 80% of participants. Acceptability will be assessed via participants' ratings on a standardized measure of treatment satisfaction and reasons for dropout. Acceptability will be indicated in 2 ways: 70% of the participants report treatment satisfaction on a standard questionnaire, and consistent collection of follow-up data across sites.
- To examine causal mechanisms and preliminary efficacy. We will examine the relationships among several proposed mediators of the expected treatment effect. We will also examine the mean change and variability of our primary outcomes.
- Conditions
- Cognitive Change
- Being tested
- High Intensity Interval Resistance Training, Stretching, Balance, and Range of motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Resistance TrainingBehavioural
During each group exercise session, the participants will be guided through a 5-minute warm-up, supervised to perform two sets of machine-based leg press, chest press, seated row, and shoulder press exercises at 30% of 1-RM, and guided through a cool-down. Each exercise set will be 40 -seconds in length with instructions to perform as many repetitions as possible followed by a 20-second rest in between sets and a three-minute rest between exercises.
Stretching, Balance, and Range of motionBehavioural
The stretching, balance, and range of motion intervention will include a rotating and varied routine of stretching exercises for large and small muscle groups, and activities to improve balance and range of motion. Participants will attend this intervention twice a week with each session lasting 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Stretching, Balance, Range of Motion | Active comparator | Participants will engage stretching, balance, and range of motion exercises 2 days per week for 12-weeks. Receives: Behavioral: Stretching, Balance, and Range of motion |
| High Intensity Interval Resistance Training | Experimental | Participants will perform resistance training exercises at high intensity intervals 2 days per week for 12-weeks. Receives: Behavioral: High Intensity Interval Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Functioning
Executive Functioning will be operationalized as an index of several computer-based tasks assessing aspects of executive functioning: Inhibition (Stroop Test), Updating (The 4-part continuous performance task), and Switching (Shifting attention task, Symbol Digit Coding).
Measured: Baseline and 12-weeks
Gradual Continuous Performance Test
Participants will make continuous responses to target picture stimuli (images of cities among distractor images of mountains). Periodically, a colored border will appear around each location, cuing the participant to attend to either the left or right picture stream. If the currently cued stream differs from their previous focus of attention, the participant will make a saccadic eye movement. At the same time as the color onset, a number will appear at each location. Participants will then make an even/odd discrimination for stimuli appearing at the to-be-attended location.
Measured: Baseline and 12-weeks
Functional Magnetic Resonance Imagining
Participants will complete a 60-minute magnetic resonance imagining session during which will acquire a high-resolution anatomical scan, an echo planar image while participants complete the Gradual Continuous Performance Test. This task is a cognitive task designed to measure the neural correlates of moment-by-moment fluctuations in the efficacy of sustained attention and attention shifting readiness, termed attentional flexibility, a resting state scan, and a diffusion tensor imaging to measure white matter tract integrity.
Measured: Baseline and 12-weeks
Secondary outcomes (11)
Brain Derived Neurotrophic Factor
Blood will be drawn using venipuncture to collect a serum sample. A blood analysis will be performed to examine brain derived neurotrophic factor, a marker suggesting an increase hippocampal neural growth.
Measured: Baseline and 12-weeks
The Physical Activity Enjoyment Scale
The physical activity enjoyment scale captures the extent to which an individual enjoys the physical activities they are currently participating in. The individual is asked to respond to 18 items with bipolar anchors on a 7-point Likert-type scale (e.g., 1=I enjoy it, 7=I hate it; 1=I feel bored, 7=I feel interested).
Measured: Baseline and 12-weeks
Community Health Activities Model Program for Seniors Activity Questionnaire for Older Adults
This physical activity questionnaire tasks participants with reporting the extent to which they participated in various occupational, transport, leisure time, and home physical activities in the previous 4 weeks (e.g., "In a typical or normal week during the past 4 weeks, did you do heavy gardening?"). If the participant indicates "yes" they next indicate the weekly frequency and duration of the activity. Following scoring, the scale produces variables capturing average weekly frequency, duration, and caloric expenditure for both total physical activity and exercise-specific activities.
Measured: Baseline and 12-weeks
Basic Psychological Need Satisfaction and Frustration Scales
he BPNSFS reflect the extent to which an individual experiences satisfaction and frustration in achieving the core human needs of relatedness, competence, and autonomy. Participants respond to 24 questions (e.g., "I feel a sense of choice and freedom in the things I undertake") on a 5-point Likert-type scale where 1 indicates "Not True at All" and 5 indicates "Completely True". The scale produces 6 subscale scores, including both frustration and satisfaction subscales for autonomy, competence, and satisfaction. Each subscale is computed as the sum of four questionnaire items, with scores ranging from 4-20, with higher scores reflecting greater satisfaction or frustration.
Measured: Baseline and 12-weeks
SF-36 Health Questionnaire
The SF-36 is a generic measure of health status/health-related quality of life that consists of two norm-based composite T-scales, mental health and physical function, and 8 subscales: physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning.
Measured: Baseline and 12-weeks
400 Meter Walk Test
The 400 meter walk test assesses walking speed and endurance in older adults on a 20 meter course. The timed walk covers 10 laps totaling 400 meters.
Measured: Baseline and 12-weeks
Short Physical Performance Battery
This measure assesses lower extremity functioning.
Measured: Baseline and 12-weeks
Stroop Test
This is a three part test. Participants will be asked to respond the words "RED", "GREEN", "YELLOW", "BLUE", and "GREEN" in different colors according to the instructions provided for each part.
Measured: Baseline and 12-weeks
Symbol Digit Coding
The symbol digit coding test measures complex information processing accuracy, complex attention, visual-perceptual speed, and information processing speed.
Measured: Baseline and 12-weeks
Four-Part Continuous Performance Test
The four-part continuous performance is a test that measures the participant's working memory and sustained attention.
Measured: Baseline and 12-weeks
Shifting Attention Test
The shifting attention test is a measure of ability to shift from one instruction set to another quickly and accurately. Participants will be instructed to match geometric objects either by shape or by color.
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Katula, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631106
- Sponsor's protocol ID
- IRB00024800
- Acronym
- LIVES
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Interventions for Vitality and Empowerment in Seniors
- ClinicalTrials.gov ID
- NCT05631106
- Acronym / sponsor ID
- LIVES / IRB00024800
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- 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.
The goal of this clinical trial is to test a newer type of high intensity interval resistance training in adults 65 years of age or older. The main aims of this study are:
- To develop study procedures in order to conduct a randomized controlled trial to test the impact of high intensity interval training on cognition in older adults. We will develop procedures for recruitment, screening, data collection, blinded randomization, HIIRT and EA interventions, safety monitoring, and data analyses.
- To determine the feasibility of using high intensity interval resistance training as an intervention. Feasibility will be shown by; 1) recruiting the target population and meeting our overall patient accrual goal of 30 participants over a 12-week period, 2) achieving an average attendance rate of ≥ 70% of the 24 scheduled sessions in the HIIRT group, 3) at least 80% retention of participants at the final follow-up assessment (week 12), and 4) successful completion of the MRI task (finishing the session with a behavioral accuracy greater than 70%) by at least 80% of participants. Acceptability will be assessed via participants' ratings on a standardized measure of treatment satisfaction and reasons for dropout. Acceptability will be indicated in 2 ways: 70% of the participants report treatment satisfaction on a standard questionnaire, and consistent collection of follow-up data across sites.
- To examine causal mechanisms and preliminary efficacy. We will examine the relationships among several proposed mediators of the expected treatment effect. We will also examine the mean change and variability of our primary outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Stretching, Balance, Range of Motion | Active comparator | Behavioral: Stretching, Balance, and Range of motionParticipants will engage stretching, balance, and range of motion exercises 2 days per week for 12-weeks. |
| High Intensity Interval Resistance Training | Experimental | Behavioral: High Intensity Interval Resistance TrainingParticipants will perform resistance training exercises at high intensity intervals 2 days per week for 12-weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Lives within 20 miles of the school
- Does not plan to travel outside the home geographic area for an extended period during the study participation
- Willing to provide informed consent
- Willing to be randomized to either lifestyle intervention group
- Willing to complete all study procedures and assessments
Key exclusion criteria (27 listed)
- Dependent on walking device
- Claustrophobia
- Performs 30 minutes of moderate intensity exercise three times per week for the previous three months
- Joint replacement or orthopedic surgery in the previous 6-months or planning to have surgery in the next 6-months
- Uncontrolled hypertension
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 |
|---|---|---|
| High Intensity Interval Resistance TrainingDuring each group exercise session, the participants will be guided through a 5-minute warm-up, supervised to perform two sets of machine-based leg press, chest press, seated row, and shoulder press exercises at 30% of 1-RM, and guided through a cool-down. Each exercise set will be 40 -seconds in length with instructions to perform as many repetitions as possible followed by a 20-second rest in between sets and a three-minute rest between exercises. | Behavioural | High Intensity Interval Resistance Training |
| Stretching, Balance, and Range of motionThe stretching, balance, and range of motion intervention will include a rotating and varied routine of stretching exercises for large and small muscle groups, and activities to improve balance and range of motion. Participants will attend this intervention twice a week with each session lasting 30 minutes. | Behavioural | Stretching, Balance, Range of Motion |
Primary outcome
Executive Functioning
Time frame: Baseline and 12-weeks
Executive Functioning will be operationalized as an index of several computer-based tasks assessing aspects of executive functioning: Inhibition (Stroop Test), Updating (The 4-part continuous performance task), and Switching (Shifting attention task, Symbol Digit Coding).
Gradual Continuous Performance Test
Time frame: Baseline and 12-weeks
Participants will make continuous responses to target picture stimuli (images of cities among distractor images of mountains). Periodically, a colored border will appear around each location, cuing the participant to attend to either the left or right picture stream. If the currently cued stream differs from their previous focus of attention, the participant will make a saccadic eye movement. At the same time as the color onset, a number will appear at each location. Participants will then make an even/odd discrimination for stimuli appearing at the to-be-attended location.
Functional Magnetic Resonance Imagining
Time frame: Baseline and 12-weeks
Participants will complete a 60-minute magnetic resonance imagining session during which will acquire a high-resolution anatomical scan, an echo planar image while participants complete the Gradual Continuous Performance Test. This task is a cognitive task designed to measure the neural correlates of moment-by-moment fluctuations in the efficacy of sustained attention and attention shifting readiness, termed attentional flexibility, a resting state scan, and a diffusion tensor imaging to measure white matter tract integrity.
11 secondary outcomes
Brain Derived Neurotrophic Factor
Time frame: Baseline and 12-weeks
The Physical Activity Enjoyment Scale
Time frame: Baseline and 12-weeks
Community Health Activities Model Program for Seniors Activity Questionnaire for Older Adults
Time frame: Baseline and 12-weeks
Basic Psychological Need Satisfaction and Frustration Scales
Time frame: Baseline and 12-weeks
SF-36 Health Questionnaire
Time frame: Baseline and 12-weeks
400 Meter Walk Test
Time frame: Baseline and 12-weeks
Short Physical Performance Battery
Time frame: Baseline and 12-weeks
Stroop Test
Time frame: Baseline and 12-weeks
Symbol Digit Coding
Time frame: Baseline and 12-weeks
Four-Part Continuous Performance Test
Time frame: Baseline and 12-weeks
Shifting Attention Test
Time frame: Baseline and 12-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Resistance Training and Stretching, Balance, and Range of motion in people with Cognitive Change, run by Wake Forest University.
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 27 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 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jeffery A Katula, Ph.D ((336) 758-3612, katulaj@wfu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Functioning (time frame: Baseline and 12-weeks). The study lists 3 primary outcomes in all. 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 30 Nov 2022.