Functionally LimitedVIVE-1NCT01198886
The Vitality, Independence, and Vigor in Elders Study I Clinical Trial
A study testing Successful Aging Program and Exercise-Nutrition Program in people with Functionally Limited and Sedentary, run by Tufts University at 17 sites in United States.
Trial summary
The primary objective of this study is to evaluate changes in functional status that result from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior housing facilities. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functionally Limited, Sedentary
- What is being tested?
- Successful Aging Program and Exercise-Nutrition Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2010to May 2014
- 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
- Age 65+
- Living at a senior housing facility
- SPPB score of 3-9
- BMI <35
- 6CIT < or = 14
- Permission of primary care provider
- Willingness to be randomized to either treatment group
Who cannot join
- Failure to provide informed consent
- Participate in >125 minutes per week of moderate to vigorous physical activity
- Moderate to severe cognitive impairment (6CIT >15)
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- Severe visual impairment (if it precludes completion of assessments and/or intervention)
- Wheelchair bound
Show all 15Show fewer
- Late-stage, progressive, degenerative neurologic disease, e.g., Parkinson's Disease, multiple sclerosis, acute lateral sclerosis.
- Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement, active inflammatory disease
- Terminal illness with life expectancy less than 12 months, as determined by a physician
- Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, severe psychiatric disorder (e.g. bipolar, schizophrenia), excessive alcohol use (>14 drinks per wk); persons with depression will not be excluded
- Surgery in the previous 6 months
- Patient who cannot be expected to comply with treatment
- Inability to obtain signed authorization from participant's primary care health care provider.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Drake Village
Arlington, Massachusetts, 02474
Nashoba Park
Ayer, Massachusetts, 01432
Compass on the Bay
Boston, Massachusetts, 02127
Chestnut Park at Cleveland Circle
Brighton, Massachusetts, 02135
Neville Place at Fresh Pond
Cambridge, Massachusetts, 02138
Youville House
Cambridge, Massachusetts, 02138
Chelmsford Crossings
Chelmsford, Massachusetts, 01824
Putnam Farms at Danvers
Danvers, Massachusetts, 01923
Standish Village at Lower Mills
Dorchester, Massachusetts, 02124
Youville Place
Lexington, Massachusetts, 02421
Methuen Village
Methuen, Massachusetts, 01844
Evans Park at Newton Center
Newton, Massachusetts, 02458
Coleman House
Newton, Massachusetts, 02459
The Falls at Cordingly Dam
Newton, Massachusetts, 02462
Golda Meir House
Newton, Massachusetts, 02466
Holland Street Center
Somerville, Massachusetts, 02144
Waltham Crossings
Waltham, Massachusetts, 02151
About this study
Official title: Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly
The primary objective of this study is to evaluate changes in functional status that result from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior housing facilities.
- The primary hypothesis is that over the 6-month intervention period subjects in the intervention group will realize significant improvements in lower extremity function compared to a control group.
Read more
Secondary objectives
To evaluate changes in nutritional status that result from the ENP.
- The secondary hypothesis is that subjects in the intervention group will realize significant increases in circulating insulin-like growth factor-1 (IGF-1) and 25-hydroxy vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to a control group.
To evaluate changes in inflammatory status that result from the ENP.
- Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6 (IL-6) compared with the control group.
To evaluate changes in psychosocial factors that result from the ENP
- The related hypothesis is that over the 6-month intervention period subjects in the intervention group will increase exercise self-efficacy, intrinsic motivation to exercise, and satisfaction of psychological needs compared to a control group.
- Additionally it is hypothesized that subjects in the intervention group will realize improvements in mood and quality of life compared to a control group.
To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing facility setting.
Read the detailed description
Older adults are the fastest growing segment of the population in many countries around the world, and the maintenance of independence has emerged as a major public health priority. Although a significant decline in physical function was once considered an inevitable consequence of aging, many studies have demonstrated that targeted exercise programs can dramatically improve physical function, even into advanced age. There is also evidence that appropriately timed protein intake is important for exercise recovery and the growth and maintenance of lean body mass. Other nutrients may be important to muscle strength and function as well. Yet many older adults have poor nutritional status. A combined exercise and nutrition program for functionally at-risk older adults, conveniently offered in the senior housing facilities where many reside, has great potential to improve functional status and quality of life in this population.
Main objective
- The primary objective of this study is to evaluate changes in functional status that result from the Exercise-Nutrition Program (ENP).
- The primary hypothesis is that over the 6-month intervention period subjects in the intervention group will realize significant improvements in lower extremity function compared to a control group.
Secondary objectives
The secondary objectives of the research project are:
- To evaluate changes in nutritional status that result from the ENP.
- The secondary hypothesis is that subjects in the intervention group will realize significant increases in circulating IGF-1 and 25-hydroxy vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to the control group.
- Subjects in the ENP will exhibit reductions in circulating plasma IL-6 concentrations, which are indicative of systemic inflammatory status.
- To evaluate changes in psychosocial factors that result from the ENP.
- The related hypothesis is that over the 6-month intervention period subjects in the intervention group will increase exercise self-efficacy, intrinsic motivation to exercise, and satisfaction of psychological needs compared to a control group.
- Additionally it is hypothesized that subjects in the intervention group will realize improvements in mood and quality of life compared to a control group.
Another major objective is to assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing center facility setting.
TRIAL DESIGN
Type of trial The study objectives will be achieved in the context of a controlled, randomized field trial. Randomization will be by site (senior housing center). Intervention group subjects will participate in the Exercise-Nutrition Program (ENP). Control group subjects will participate in the Successful Aging Program (SAP), which will provide them with useful skills and an adequate attention control, but will not affect the primary outcome of this study.
Subjects, groups and centers:
In each study group the number of subjects to complete the study protocol will be 40 (see also 9.3 statistical section). Assuming a conservative dropout rate of 10% after the 3 month intervention and 15% at the end of the 6 month study, a sample of 53 subjects per group, or 106 total, will be required to be enrolled in the study. 16-20- senior housing centers will be recruited and each will run one class with an average size of at least 5 subjects (maximum 25 subjects).
Sites will be assigned to one of 2 groups:
Group 1: Exercise-Nutrition Program (ENP) Group 2: Successful Aging Program (SAP)
Duration of subject participation:
Subjects will undergo the proposed intervention for 6 months. The target population for this study will be elderly people (65 yrs+) living in senior housing centers.
- Conditions
- Functionally Limited, Sedentary
- Being tested
- Successful Aging Program, Exercise-Nutrition Program
- Keywords
- Mobility disability, Older adults, Physical activity, Nutritional status
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successful Aging ProgramOther
Once per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine.
Exercise-Nutrition ProgramOther
Targeted exercise program offered 3-days per week at the study participants place of residence (senior housing facility). Other means to encourage physical activity outside of these exercise classes will be available. A nutrient-rich protein carbohydrate experimental beverage will be taken following the exercise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Successful Aging Program | Placebo comparator | Not described Receives: Other: Successful Aging Program |
| Exercise-Nutrition Program | Experimental | Not described Receives: Other: Exercise-Nutrition Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
Tests of functional mobility that include strength and balance. Appropriate for older adults.
Measured: Baseline, 3 months, 6 months, and 12 months into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functionally LimitedStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam E Nelson, PhD, Study director, Tufts UniversitySara C. Folta, PhD, Principal investigator, Tufts UniversityRoger F. Fielding, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198886
- Sponsor's protocol ID
- 1006010
- Other IDs
- 09.37.CLI
- Acronym
- VIVE-1
- Status last verified
- May 2015
- First submitted
- 8 Sep 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Corcoran MP, Chui KK, White DK, Reid KF, Kirn D, Nelson ME, Sacheck JM, Folta SC, Fielding RA. Accelerometer Assessment of Physical Activity and Its Association with Physical Function in Older Adults Residing at Assisted Care Facilities. J Nutr Health Aging. 2016;20(7):752-8. doi: 10.1007/s12603-015-0640-7.
PubMed 27499309
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitality, Independence, and Vigor in Elders Study (VIVE Study): Effects of an Exercise and Nutrition Program on Functionality in the Elderly
- ClinicalTrials.gov ID
- NCT01198886
- Acronym / sponsor ID
- VIVE-1 / 1006010
- Conditions
- Functionally Limited, Sedentary
- Keywords
- Mobility disability, Older adults, Physical activity, Nutritional status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Sep 2010 (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 primary objective of this study is to evaluate changes in functional status that result from an Exercise-Nutrition Program (ENP) targeted toward older adults residing at senior housing facilities.
- The primary hypothesis is that over the 6-month intervention period subjects in the intervention group will realize significant improvements in lower extremity function compared to a control group.
Secondary objectives
To evaluate changes in nutritional status that result from the ENP.
- The secondary hypothesis is that subjects in the intervention group will realize significant increases in circulating insulin-like growth factor-1 (IGF-1) and 25-hydroxy vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to a control group.
To evaluate changes in inflammatory status that result from the ENP.
- Subjects in the ENP group will exhibit reduced concentrations of circulating interleukin-6 (IL-6) compared with the control group.
To evaluate changes in psychosocial factors that result from the ENP
- The related hypothesis is that over the 6-month intervention period subjects in the intervention group will increase exercise self-efficacy, intrinsic motivation to exercise, and satisfaction of psychological needs compared to a control group.
- Additionally it is hypothesized that subjects in the intervention group will realize improvements in mood and quality of life compared to a control group.
To assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing facility setting.
Detailed description
Older adults are the fastest growing segment of the population in many countries around the world, and the maintenance of independence has emerged as a major public health priority. Although a significant decline in physical function was once considered an inevitable consequence of aging, many studies have demonstrated that targeted exercise programs can dramatically improve physical function, even into advanced age. There is also evidence that appropriately timed protein intake is important for exercise recovery and the growth and maintenance of lean body mass. Other nutrients may be important to muscle strength and function as well. Yet many older adults have poor nutritional status. A combined exercise and nutrition program for functionally at-risk older adults, conveniently offered in the senior housing facilities where many reside, has great potential to improve functional status and quality of life in this population.
Main objective
- The primary objective of this study is to evaluate changes in functional status that result from the Exercise-Nutrition Program (ENP).
- The primary hypothesis is that over the 6-month intervention period subjects in the intervention group will realize significant improvements in lower extremity function compared to a control group.
Secondary objectives
The secondary objectives of the research project are:
- To evaluate changes in nutritional status that result from the ENP.
- The secondary hypothesis is that subjects in the intervention group will realize significant increases in circulating IGF-1 and 25-hydroxy vitamin D (25(OH)D) and demonstrate improvements in nutritional status compared to the control group.
- Subjects in the ENP will exhibit reductions in circulating plasma IL-6 concentrations, which are indicative of systemic inflammatory status.
- To evaluate changes in psychosocial factors that result from the ENP.
- The related hypothesis is that over the 6-month intervention period subjects in the intervention group will increase exercise self-efficacy, intrinsic motivation to exercise, and satisfaction of psychological needs compared to a control group.
- Additionally it is hypothesized that subjects in the intervention group will realize improvements in mood and quality of life compared to a control group.
Another major objective is to assess the feasibility of conducting the Exercise-Nutrition Program in a senior housing center facility setting.
TRIAL DESIGN
Type of trial The study objectives will be achieved in the context of a controlled, randomized field trial. Randomization will be by site (senior housing center). Intervention group subjects will participate in the Exercise-Nutrition Program (ENP). Control group subjects will participate in the Successful Aging Program (SAP), which will provide them with useful skills and an adequate attention control, but will not affect the primary outcome of this study.
Subjects, groups and centers:
In each study group the number of subjects to complete the study protocol will be 40 (see also 9.3 statistical section). Assuming a conservative dropout rate of 10% after the 3 month intervention and 15% at the end of the 6 month study, a sample of 53 subjects per group, or 106 total, will be required to be enrolled in the study. 16-20- senior housing centers will be recruited and each will run one class with an average size of at least 5 subjects (maximum 25 subjects).
Sites will be assigned to one of 2 groups:
Group 1: Exercise-Nutrition Program (ENP) Group 2: Successful Aging Program (SAP)
Duration of subject participation:
Subjects will undergo the proposed intervention for 6 months. The target population for this study will be elderly people (65 yrs+) living in senior housing centers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful Aging Program | Placebo comparator | Other: Successful Aging Program |
| Exercise-Nutrition Program | Experimental | Other: Exercise-Nutrition Program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65+
- Living at a senior housing facility
- SPPB score of 3-9
- BMI <35
- 6CIT < or = 14
Key exclusion criteria (15 listed)
- Failure to provide informed consent
- Participate in >125 minutes per week of moderate to vigorous physical activity
- Moderate to severe cognitive impairment (6CIT >15)
- Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- Severe visual impairment (if it precludes completion of assessments and/or intervention)
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 |
|---|---|---|
| Successful Aging ProgramOnce per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine. | Other | Successful Aging Program |
| Exercise-Nutrition ProgramTargeted exercise program offered 3-days per week at the study participants place of residence (senior housing facility). Other means to encourage physical activity outside of these exercise classes will be available. A nutrient-rich protein carbohydrate experimental beverage will be taken following the exercise sessions. | Other | Exercise-Nutrition Program |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: Baseline, 3 months, 6 months, and 12 months into the study
Tests of functional mobility that include strength and balance. Appropriate for older adults.
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 13 May 2015.
- Derived from this study: PubMed 27499309Corcoran MP, Chui KK, White DK, Reid KF, Kirn D, Nelson ME, Sacheck JM, Folta SC, Fielding RA. Accelerometer Assessment of Physical Activity and Its Association with Physical Function in Older Adults Residing at Assisted Care Facilities. J Nutr Health Aging. 2016;20(7):752-8. doi: 10.1007/s12603-015-0640-7.
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.
Miriam E Nelson, PhD study director
Tufts University
Sara C. Folta, PhD principal investigator
Tufts University
Roger F. Fielding, PhD principal investigator
Tufts University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Successful Aging Program and Exercise-Nutrition Program in people with Functionally Limited and Sedentary, run by Tufts University at 17 sites 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 7 inclusion and 15 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. Some participants in this study may receive a placebo. 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?
Short Physical Performance Battery (SPPB) (time frame: Baseline, 3 months, 6 months, and 12 months into the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01198886, which also lists 1 linked publication.
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 13 May 2015.