InflammationTALIEHONCT04965246
Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
A study testing Physical Activity in people with Inflammation and Cognitive Impairment, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control… Read more about this study
- Who is it for?
- Ages 65 to 84 years, women only
- Conditions the study is for
- Inflammation, Cognitive Impairment, Anxiety
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 8 Jul 2024
- 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 to 84 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Female
- Age 65-84 years
- 1-10 years post-breast cancer treatment
- Body mass index ≥30
- ≥1 drink per week over the last month
- ≥21 on the Telephone Interview For Cognitive Status
Show all 10Show fewer
- ≤7 on the Alcohol Use Disorder Identification Test
- Fluent in written and spoken English
- Must be able to provide and understand informed consent
- Primary physician approval
Who cannot join
- Body mass index <30
- < 21 on the Telephone Interview for Cognitive Status
- >7 on the Alcohol Use Disorder Inventory Test
- Other neurological or major psychiatric disorders
- Significant heart or lung disease
- Limited life expectancy
- Other factors that could potentially limit ability to participate fully in the intervention
- Self-reporting achieving over 150 minutes of moderate-to-vigorous physical activity per week.
Trial locations and contacts
1 site in 1 country.
About this study
The Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.
Read the detailed description
The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group.
Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.
- Conditions
- Inflammation, Cognitive Impairment, Anxiety, Alcohol Drinking
- Being tested
- Physical Activity, Usual Care
- Medical subject headings
- Inflammation, Cognitive Dysfunction, Anxiety Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
The physical activity program will focus on increasing physical activity, starting with a target of 100 minutes per week. The session durations will build over time to 150 minutes per week. Participants will be instructed to walk, or engage in other forms of light-intensity physical activity to achieve these goals. Participants will be instructed on the use of the ratings of perceived exertion scale (6-20). As the participants' health and fitness status improves, frequency, intensity, and session duration will be modified accordingly during weekly support calls. As participants will enter the study engaging in varying levels of physical activity, goals will be responsive to the most recent week's achieved minutes.
Usual CareOther
Participants in the usual care group will receive no intervention
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | the physical activity intervention will be structured to increase light-intensity aerobic physical activity, to achieve a total of 150 minutes per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity Receives: Behavioral: Physical Activity |
| Usual care | Other | Participants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of inflammation: C-reactive protein
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Measured: Baseline
Markers of inflammation: C-reactive protein
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Measured: 15 weeks
Secondary outcomes (45)
Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Measured: Baseline
Markers of inflammation-Interleukin 6
A cytokine multiplex will assess markers of inflammation, including Interleukin 6
Measured: 15 weeks
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Measured: Baseline
Markers of inflammation-Tumor Necrosis Factor Alpha
A cytokine multiplex will assess markers of inflammation, including Tumor Necrosis Factor Alpha
Measured: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.
Measured: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments scores range from 0-72, higher scores indicate better quality of life.
Measured: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life.
Measured: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life scores range from 0-16, higher scores indicate better quality of life.
Measured: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.
Measured: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others scores range from 0-16, higher scores indicate better quality of life.
Measured: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.
Measured: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities scores range from 0-28, higher scores indicate better quality of life.
Measured: 15 weeks
Anxiety Symptoms-State-Trait Anxiety Inventory
State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety.
Measured: Baseline
Anxiety Symptoms-State-Trait Anxiety Inventory
State and trait anxiety are measured using the State and Trait subscales of the State-Trait Anxiety Inventory (Spielberger, 2010, Corsini Encycl of Psychol).The State-Trait Anxiety Inventory has 40 items, 20 items allocated to each of the subscales. State-Trait Anxiety Inventory varies from a minimum score of 20 to a maximum score of 80, higher scores indicate higher anxiety.
Measured: 15 weeks
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety
Measured: Baseline
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Anxiety subscale measures patient reported anxiety symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher anxiety
Measured: 15 weeks
Depressive Symptoms
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression
Measured: Baseline
Depressive Symptoms
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - depression subscale measures patient reported depressive symptoms. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher depression
Measured: 15 weeks
Physical Function-The Patient-Reported Outcomes Measurement Information System
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function
Measured: Baseline
Physical Function-The Patient-Reported Outcomes Measurement Information System
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - physical function subscale measures patient reported physical function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher physical function
Measured: 15 weeks
Fatigue
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue.
Measured: Baseline
Fatigue
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - fatigue subscale measures patient reported fatigue. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher fatigue.
Measured: 15 weeks
Sleep Disturbance
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviationof 10. Higher scores indicate higher Sleep Disturbance.
Measured: Baseline
Sleep Disturbance-PROMIS-57
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Sleep Disturbance subscale measures patient reported Sleep Disturbance. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Sleep Disturbance.
Measured: 15 weeks
Ability to Participate in Social Roles and Activities
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities
Measured: baseline
Ability to Participate in Social Roles and Activities
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Ability to Participate in Social Roles and Activities subscale measures patient reported Ability to Participate in Social Roles and Activities. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Ability to Participate in Social Roles and Activities
Measured: 15 weeks
Pain interference
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference
Measured: Baseline
Pain interference
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain interference
Measured: 15 weeks
Pain intensity
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity
Measured: Baseline
Pain intensity
The Patient-Reported Outcomes Measurement Information System PROMIS®-57 Profile v2.1 - Pain interference subscale measures patient reported pain interference. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher Pain intensity
Measured: 15 weeks
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Measured: Baseline
Alcohol consumption
A questionnaire probing the number of alcohol drinks consumed in the past 7 days
Measured: 15 weeks
Physical Function-walk test
The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.
Further distances indicate greater physical function
Measured: Baseline
Physical Function-walk test
The six minute walking test will be administered to assess physical function. Participants will aim to walk as far as possible for 6 minutes.
Further distances indicate greater physical function
Measured: 15 weeks
Mobile Monitoring of Cognitive Change
Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments.
Measured: Week 1-2
Mobile Monitoring of Cognitive Change
Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments.
Measured: Week 7-8
Mobile Monitoring of Cognitive Change
Ecological momentary assessment procedures for measuring both self-report and objective cognitive function will be used in 14 day bursts. These ecological momentary assessments protocols assess many of the same domains captured in other self-report and objective cognitive function measures, shortened and adapted for daily assessments.
Measured: Week 14-15
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Measured: Week 1-2
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Measured: Week 7-8
Alcohol consumption-daily
Ecological momentary assessment procedures for measuring the number of drinks consumed in the past 24 hours will be assessed in 14 day bursts
Measured: Week 14-15
Alcohol Use Disorder
The Alcohol Use Disorders Identification Test is a simple and effective method of screening for unhealthy alcohol use, defined as risky or hazardous consumption or any alcohol use disorder. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
Measured: Baseline
Telephone Interview for Cognitive Status
The Telephone Interview for Cognitive Status is a brief, standardized test of cognitive functioning that was developed for use in situations where in-person cognitive screening is impractical or inefficient. The Telephone Interview for Cognitive Status will be used to screen for moderate-to-severe cognitive impairment. Scores 20 of lower indicate moderate-to-severe cognitive impairment
Measured: Baseline
Demographics
Age, height, weight, family income, education level, age at diagnosis, time since diagnosis, injury history, diabetic status, and whether they are currently receiving treatment for mental health will be assessed at baseline
Measured: Baseline
Acceptability-the proportion of older adults who agree to participate
The proportion of older adults who agree to participate among those deemed eligible.
Measured: Baseline
Feasibility-the proportion of older adults who complete at least 50% of the physical activity intervention
The percentage of those randomized to the physical activity intervention that complete at least 50% of the physical activity intervention. Participants will be instructed by a project manager during weekly support calls to accumulate a specific amount of physical activity each week. Participants who self-report completing at least 50% of the physical activity, determined by the physical activity log, will be deemed compliant.
Measured: Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start22 Nov 2021
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Penn State Health Milton S Hershey Medical Center
- Investigators
- Kathryn Schmitz, PhD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965246
- Sponsor's protocol ID
- PSCI 21-045
- Acronym
- TALIEHO
- Status last verified
- Dec 2024
- First submitted
- 7 Jul 2021
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Assessing Light Intensity Exercise on the Health of Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04965246
- Acronym / sponsor ID
- TALIEHO / PSCI 21-045
- Conditions
- Inflammation, Cognitive Impairment, Anxiety, Alcohol Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 16 Jul 2021 (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 Trial Assessing Light-Intensity Exercise on the Health of Older Breast Cancer Survivors pilot randomized controlled trial aims to evaluate the efficacy of a home-based, light-intensity physical activity intervention among 56 obese, older adult breast cancer survivors, in comparison to a usual care control condition.
Detailed description
The investigators will recruit 56 obese, older adult breast cancer survivors at least 1 year, and up to 10 years post-breast cancer treatment, and randomize them to either a 15 week light-intensity physical activity intervention, or usual care group.
Intervention: The participants will receive weekly support calls, and instructed to increase their light-intensity physical activity, to achieve at least 150 minutes per week. The frequency, intensity, time, and type of physical activity will be modified to maximize adherence and compliance. The support calls developed for this trial target older adults' capabilities, opportunities, and motivations for physical activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical Activitythe physical activity intervention will be structured to increase light-intensity aerobic physical activity, to achieve a total of 150 minutes per week. The intervention will also include weekly support calls from research staff to improve compliance to physical activity |
| Usual care | Other | Other: Usual CareParticipants randomized to the usual care control group will serve as the control group for 15 weeks, and receive no intervention during this time. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Female
- Age 65-84 years
- 1-10 years post-breast cancer treatment
- Body mass index ≥30
- ≥1 drink per week over the last month
Key exclusion criteria (8 listed)
- Body mass index <30
- < 21 on the Telephone Interview for Cognitive Status
- >7 on the Alcohol Use Disorder Inventory Test
- Other neurological or major psychiatric disorders
- Significant heart or lung disease
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 ActivityThe physical activity program will focus on increasing physical activity, starting with a target of 100 minutes per week. The session durations will build over time to 150 minutes per week. Participants will be instructed to walk, or engage in other forms of light-intensity physical activity to achieve these goals. Participants will be instructed on the use of the ratings of perceived exertion scale (6-20). As the participants' health and fitness status improves, frequency, intensity, and session duration will be modified accordingly during weekly support calls. As participants will enter the study engaging in varying levels of physical activity, goals will be responsive to the most recent week's achieved minutes. | Behavioural | Physical activity |
| Usual CareParticipants in the usual care group will receive no intervention | Other | Usual care |
Primary outcome
Markers of inflammation: C-reactive protein
Time frame: Baseline
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
Markers of inflammation: C-reactive protein
Time frame: 15 weeks
A cytokine multiplex will assess markers of inflammation, including C-reactive protein
45 secondary outcomes
Markers of inflammation-Interleukin 6
Time frame: Baseline
Markers of inflammation-Interleukin 6
Time frame: 15 weeks
Markers of inflammation-Tumor Necrosis Factor Alpha
Time frame: Baseline
Markers of inflammation-Tumor Necrosis Factor Alpha
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-Perceived Cognitive Impairments
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-Impact of perceived cognitive impairments on quality of life
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-comments from others
Time frame: 15 weeks
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
Time frame: Baseline
The Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive abilities
Time frame: 15 weeks
Anxiety Symptoms-State-Trait Anxiety Inventory
Time frame: Baseline
Anxiety Symptoms-State-Trait Anxiety Inventory
Time frame: 15 weeks
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
Time frame: Baseline
Anxiety Symptoms-The Patient-Reported Outcomes Measurement Information System
Time frame: 15 weeks
Depressive Symptoms
Time frame: Baseline
Depressive Symptoms
Time frame: 15 weeks
Physical Function-The Patient-Reported Outcomes Measurement Information System
Time frame: Baseline
Physical Function-The Patient-Reported Outcomes Measurement Information System
Time frame: 15 weeks
Fatigue
Time frame: Baseline
Fatigue
Time frame: 15 weeks
Sleep Disturbance
Time frame: Baseline
Sleep Disturbance-PROMIS-57
Time frame: 15 weeks
Ability to Participate in Social Roles and Activities
Time frame: baseline
Ability to Participate in Social Roles and Activities
Time frame: 15 weeks
Pain interference
Time frame: Baseline
Pain interference
Time frame: 15 weeks
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: 15 weeks
Alcohol consumption
Time frame: Baseline
Alcohol consumption
Time frame: 15 weeks
Physical Function-walk test
Time frame: Baseline
Physical Function-walk test
Time frame: 15 weeks
Mobile Monitoring of Cognitive Change
Time frame: Week 1-2
Mobile Monitoring of Cognitive Change
Time frame: Week 7-8
Mobile Monitoring of Cognitive Change
Time frame: Week 14-15
Alcohol consumption-daily
Time frame: Week 1-2
Alcohol consumption-daily
Time frame: Week 7-8
Alcohol consumption-daily
Time frame: Week 14-15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
Kathryn Schmitz, PhD principal investigator
Milton S. Hershey Medical Center
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 in people with Inflammation and Cognitive Impairment, run by Milton S. Hershey Medical Center at 1 site in United States.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jan 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of inflammation: C-reactive protein (time frame: Baseline). The study lists 2 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 15 Jan 2025.