Chronic IllnessesINSPIRENCT02464254
Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
A study testing Physical activity plus positive affect and Physical activity plus education in people with Chronic Illnesses, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Chronic Illnesses
- What is being tested?
- Physical activity plus positive affect and Physical activity plus education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Dec 2020
- 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 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Charlson Index greater or equal to 3
Who cannot join
- Cognitive impairment
- Inability to walk
- < 12 month anticipated survival
- enrollment in other behavioral programs
- lack of medical approval to participate
- substance/alcohol dependence or participation in a substance abuse treatment program within 12 months
- major psychiatric illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.
Read the detailed description
Older adults with multiple chronic diseases are at high risk for both disability and adverse clinical events, outcomes that can be improved with physical activity, but there have been no trials to establish physical activity recommendations or clinical guidelines for this vulnerable population. A recent randomized controlled trial conducted by Dr. Peterson established the efficacy of inducing positive affect-a feeling of happiness and well-being-in motivating physical activity in older adults with cardiovascular disease. This new randomized controlled trial will pilot test the a new PAIRE (Positive Affect Induction for Regular Exercise) intervention that is specific to older adults with multiple high-risk chronic illnesses versus an educational control group. This work is innovative because it will translate the benefits of a proven intervention focused on positive affect to increase physical activity in older adults with multiple high-risk chronic illnesses, one that is tailored to the clinical and psychosocial challenges of this particularly vulnerable population. This work is significant because an effective intervention promoting physical activity will improve outcomes for older adults with multiple high-risk chronic diseases, and currently one does not exist.
- Conditions
- Chronic Illnesses
- Being tested
- Physical activity plus positive affect, Physical activity plus education
- Keywords
- Physical activity, positive affect, older adults, aging
- Medical subject headings
- Chronic Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity plus positive affectBehavioural
Subjects will be randomized to a physical activity goal and will receive the positive affect component.
Physical activity plus educationBehavioural
Subjects will be randomized to a physical activity goal and will receive the educational component.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity plus positive affect | Experimental | Subjects will be randomized to a physical activity goal and the positive affect component Receives: Behavioral: Physical activity plus positive affect; Behavioral: Physical activity plus education |
| Physical activity plus education | Active comparator | Subjects will be randomized to a physical activity goal and education Receives: Behavioral: Physical activity plus education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kilocalories/week assessed by Objective measure of activity with accelerometry
FitBit
Measured: baseline to 12 months
Secondary outcomes (2)
Kilocalories/week assessed by Subjective measure of activity by self-report
Measured: baseline to 12 months
Function/disability assessed by objective and subjective reports of functional ability
Measured: baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startApr 2016
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Janey Peterson, EdD MS RN, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464254
- Sponsor's protocol ID
- 1303013686
- Other IDs
- 1K23AG042869-01A1
- Acronym
- INSPIRE
- Status last verified
- Jun 2019
- First submitted
- 2 Jun 2015
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the main article reporting the results, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Support Participation in Regular Exercise in the Elderly (INSPIRE)
- ClinicalTrials.gov ID
- NCT02464254
- Acronym / sponsor ID
- INSPIRE / 1303013686
- Conditions
- Chronic Illnesses
- Keywords
- Physical activity, positive affect, older adults, aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2016
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 8 Jun 2015 (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.
The investigators will conduct a 1-year prospective and randomized study to evaluate the initial efficacy of positive affect vs. an educational control to motivate physical activity in older adults with high burdens of chronic disease.
Detailed description
Older adults with multiple chronic diseases are at high risk for both disability and adverse clinical events, outcomes that can be improved with physical activity, but there have been no trials to establish physical activity recommendations or clinical guidelines for this vulnerable population. A recent randomized controlled trial conducted by Dr. Peterson established the efficacy of inducing positive affect-a feeling of happiness and well-being-in motivating physical activity in older adults with cardiovascular disease. This new randomized controlled trial will pilot test the a new PAIRE (Positive Affect Induction for Regular Exercise) intervention that is specific to older adults with multiple high-risk chronic illnesses versus an educational control group. This work is innovative because it will translate the benefits of a proven intervention focused on positive affect to increase physical activity in older adults with multiple high-risk chronic illnesses, one that is tailored to the clinical and psychosocial challenges of this particularly vulnerable population. This work is significant because an effective intervention promoting physical activity will improve outcomes for older adults with multiple high-risk chronic diseases, and currently one does not exist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity plus positive affect | Experimental | Behavioral: Physical activity plus positive affect, Behavioral: Physical activity plus educationSubjects will be randomized to a physical activity goal and the positive affect component |
| Physical activity plus education | Active comparator | Behavioral: Physical activity plus educationSubjects will be randomized to a physical activity goal and education |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Charlson Index greater or equal to 3
Key exclusion criteria (7 listed)
- Cognitive impairment
- Inability to walk
- < 12 month anticipated survival
- enrollment in other behavioral programs
- lack of medical approval to participate
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 activity plus positive affectSubjects will be randomized to a physical activity goal and will receive the positive affect component. | Behavioural | Physical activity plus positive affect |
| Physical activity plus educationSubjects will be randomized to a physical activity goal and will receive the educational component. | Behavioural | Physical activity plus education, Physical activity plus positive affect |
Primary outcome
Kilocalories/week assessed by Objective measure of activity with accelerometry
Time frame: baseline to 12 months
FitBit
2 secondary outcomes
Kilocalories/week assessed by Subjective measure of activity by self-report
Time frame: baseline to 12 months
Function/disability assessed by objective and subjective reports of functional ability
Time frame: baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the main article reporting the results, after deidentification
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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.
Janey Peterson, EdD MS RN principal investigator
Weill Medical College of Cornell 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 plus positive affect and Physical activity plus education in people with Chronic Illnesses, run by Weill Medical College of Cornell University 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 1 inclusion and 7 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 21 Jun 2019. 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?
Results are not available in the source record.
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?
Kilocalories/week assessed by Objective measure of activity with accelerometry (time frame: baseline to 12 months). 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 21 Jun 2019.