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Mobility LimitationENGAGENCT03430271

Enhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: the ENGAGE Pilot Study

A study testing Physical Activity Intervention and Healthy Aging Intervention in people with Mobility Limitation, run by Tufts University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to determine the safety and feasibility of translating a physical activity intervention (LIFE Study) into a community setting. Study outcomes include physical performance, safety, and feasibility of conducting the LIFE PA intervention in a community setting. Read more about this study

Who is it for?
Ages 65 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Mobility Limitation
What is being tested?
Physical Activity Intervention and Healthy Aging Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
2 sitesUnited States
Study dates
12 May 2015to 30 Jun 2016
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 89 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Males and Females age ≥ 65 and ≤89 years
  • Community dwelling
  • Short Physical Performance Battery ≤ 9
  • No participation in a structured physical activity program within the previous 3 months
  • Willingness to be randomized and participate for 24 weeks
  • Written permission from primary care physician
  • Having obtained his/her informed consent

Who cannot join

  • Acute or terminal illness
  • Modified Mini-Mental State Examination Score <80(<76 if African American)*
  • Myocardial Infarction in the previous 6 months
  • Symptomatic coronary artery disease
  • Upper or lower extremity fracture in the previous 6 months
  • Resting blood pressure >180/100 mmHg
Show all 9Show fewer
  • Unable to communicate due to severe hearing loss or speech disorder
  • Severe visual impairment that may preclude participation in the study assessments or interventions
  • Non-English speaking

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Jean Mayer Human Nutrition Research Center on Aging at Tufts University

    Boston, Massachusetts, 02111

  • Somerville Council on Aging Holland Street Senior Center

    Somerville, Massachusetts, 02144

Other trials in United States

About this study

Official title: ENhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: The ENGAGE Pilot Study

This study will be conducted to determine the safety and feasibility of translating a physical activity intervention (LIFE Study) into a community setting. Study outcomes include physical performance, safety, and feasibility of conducting the LIFE PA intervention in a community setting.

Read the detailed description

Older adults who lose their mobility experience a poorer quality of life, are less likely to remain independent in the community and have higher rates of chronic disease, falls and mortality. Recent results from the Lifestyle Interventions and Independence for Elders (LIFE) study demonstrated that a structured program of physical activity (PA) reduced the onset of major mobility disability in at-risk older adults by up to 28% over a 2.6 year period. Despite the public health significance of this study, to-date no study has attempted to translate LIFE PA to broader populations of at-risk older adults in community-based settings. To address this knowledge gap, and to aid the design of a larger pragmatic trial of LIFE PA in community-based settings, the investigators conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study. The investigators examined the safety and feasibility of translating LIFE PA into the existing infrastructure of a community-based senior center. The investigators also explored the preliminary real-world effectiveness of PA on physical performance and several other important health related outcomes for older persons, including cognitive function, quality of life, depressive symptoms and frequency of falling.

Being tested
Physical Activity Intervention, Healthy Aging Intervention
Medical subject headings
Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity InterventionOther

    Participants in this arm will complete exercise sessions 1 time per week for 24 weeks. An optional, second PA session will also be offered to PA participants. The exercise sessions will be multimodal and involve walking, lower extremity strengthening exercises, flexibility and balance training.

  • Healthy Aging InterventionOther

    Participants will attend health education workshops on topics of relevance to older adults. Workshops will be offered weekly in a group setting, and participants will be required to attend biweekly.

Study groups in NCT03430271
Study groupRoleWhat they receive
Physical Activity (PA) InterventionActive comparatorNot described
Receives: Other: Physical Activity Intervention
Health Education (HE) InterventionPlacebo comparatorNot described
Receives: Other: Healthy Aging Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. This study will assess the safety of translating LIFE PA to a real-world community based setting by monitoring the occurrence of adverse events and serious adverse events.

    Safety will be measured by the number of adverse events and serious adverse events. The investigators will compare the rates of adverse events and serious adverse events between the physical activity and healthy aging education intervention randomized arms.

    Measured: 6 months

  2. This study will assess the feasibility of translating LIFE PA to a real-world community based setting with adequate PA adherence in the community by measuring intervention adherence and retention.

    Intervention adherence is measured by percent attendance (number of visits attended/total number of scheduled visits). Successful adherence will be defined by an attendance rate of >60%. This will be used as an index of feasibility.

    Measured: 6 months

Secondary outcomes (11)

  1. Accelerometry

    Accelerometry will objectively measure levels of physical activity intensity (light/moderate) and sedentary time. Accelerometry will be measured by GT3X+, Actigraph, Pensacola, FL. The actigraph will be worn for a 7-day period during waking hours during baseline and follow-up. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks

    Measured: 6 months

  2. Short physical performance battery (SPPB) test (an additional interim SPPB assessment will be conducted at week 12)

    The SPPB test will be evaluated using a 4m gait speed test, chair stand test (consisting of five consecutive chair stands), and a balance test (measured by a side-by-side, semi-tandem, and full tandem stand). This test will assess the time to complete a 4m walk and a chair stand test, as well as the time each participant can hold the balance positions (up to 10 seconds). Time will be measured in minutes and seconds. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  3. 400 meter walk

    The 400 meter walk will be a timed measurement of 10 laps around a 20 meter course or until the participant is unable to continue. Time will be measured in minutes and seconds. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  4. Quality of Well-Being

    This assessment will be measured using the Quality of Well-Being (QWB) Scale questionnaire. This scale provides a comprehensive measure of health-related quality of life that assesses health symptoms and functioning. The questionnaire is scored using a 0 to 1.0 scale (0 representing death, 1.0 representing asymptomatic full function). This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  5. Depressive symptoms

    Depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D), which is designed to measure depressive symptomology in the general population. The Scale consists of 20 questions, which are assigned a response score of 0, 1, 2 or 3 depending upon whether the item is worded positively or negatively. Possible range of total scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. A cutoff score of 16 or greater reflects individuals at risk for clinical depression. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  6. Cognitive performance

    Cognitive performance will be assessed using the Digit Symbol Substitution Test (DSST). The DSST is a measure of attention and perceptual speed in which subjects are given a series of numbered symbols and then asked to draw the appropriate symbols below a list of random numbers. The score is the number of correctly made matches in 2 minutes. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  7. Hand-Grip Strength

    Grip strength will be measured in the dominant hand with a Jamar Handheld Dynamometer. Participants will be asked to perform a maximal isometric contraction. Strength will be measured in kilograms. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  8. Nutrition Status

    Nutrition Status will be assessed using the Mini Nutrition Assessment, Short Form (MNA-SF). The MNA-SF is a validated nutrition screening assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  9. Falls history

    Participants will be asked about any recent falls they have experienced at each assessment visit and will be asked to record any falls that they experience throughout the trial on a calendar provided by the study interventionist. Falls history will be reported from baseline to 24 weeks.

    Measured: 6 months

  10. Isometric Leg strength

    Maximal isometric leg strength will be assessed using a portable electronic weight scale. Participants will be instructed to kick their leg as hard as possible three times on each leg. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

  11. Complex Walking Tasks (CWT's)

    Subjects will be asked to walk on an even surface for 7 meters as fast as possible while remaining safe. They will then be asked to repeat the walk at their usual pace while simultaneously subtracting 3 from 50 and keep subtracting until the 7 meter walk is completed. The walk will be timed (measured in minutes with a stop watch and each subtraction will be recorded. This outcome measure will be assessed by the change in measurements between baseline and 24 weeks.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start12 May 2015
  3. Primary completion30 Jun 2016
  4. Study completion30 Jun 2016

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The ENGAGE Somerville Study is designed as a single blind, randomized-controlled, parallel-group pilot study. This study plans to enroll up to 50 participants to be randomized into the PA or health aging intervention.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430271
Sponsor's protocol ID
11624
Acronym
ENGAGE
Status last verified
Feb 2018
First submitted
26 Oct 2017
Last updated
14 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gardener EA, Huppert FA, Guralnik JM, Melzer D. Middle-aged and mobility-limited: prevalence of disability and symptom attributions in a national survey. J Gen Intern Med. 2006 Oct;21(10):1091-6. doi: 10.1111/j.1525-1497.2006.00564.x.

    PubMed 16970558

  • Leveille SG, Guralnik JM, Ferrucci L, Langlois JA. Aging successfully until death in old age: opportunities for increasing active life expectancy. Am J Epidemiol. 1999 Apr 1;149(7):654-64. doi: 10.1093/oxfordjournals.aje.a009866.

    PubMed 10192313

  • Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

    PubMed 10811152

  • Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

    PubMed 8126356

  • Hardy SE, Kang Y, Studenski SA, Degenholtz HB. Ability to walk 1/4 mile predicts subsequent disability, mortality, and health care costs. J Gen Intern Med. 2011 Feb;26(2):130-5. doi: 10.1007/s11606-010-1543-2.

    PubMed 20972641

  • Hubert HB, Bloch DA, Oehlert JW, Fries JF. Lifestyle habits and compression of morbidity. J Gerontol A Biol Sci Med Sci. 2002 Jun;57(6):M347-51. doi: 10.1093/gerona/57.6.m347.

    PubMed 12023263

  • LaCroix AZ, Guralnik JM, Berkman LF, Wallace RB, Satterfield S. Maintaining mobility in late life. II. Smoking, alcohol consumption, physical activity, and body mass index. Am J Epidemiol. 1993 Apr 15;137(8):858-69. doi: 10.1093/oxfordjournals.aje.a116747.

    PubMed 8484377

  • Stuck AE, Walthert JM, Nikolaus T, Bula CJ, Hohmann C, Beck JC. Risk factors for functional status decline in community-living elderly people: a systematic literature review. Soc Sci Med. 1999 Feb;48(4):445-69. doi: 10.1016/s0277-9536(98)00370-0.

    PubMed 10075171

  • Buchner DM, Beresford SA, Larson EB, LaCroix AZ, Wagner EH. Effects of physical activity on health status in older adults. II. Intervention studies. Annu Rev Public Health. 1992;13:469-88. doi: 10.1146/annurev.pu.13.050192.002345.

    PubMed 1599599

  • Dolansky MA, Moore SM. Effects of cardiac rehabilitation on the recovery outcomes of older adults after coronary artery bypass surgery. J Cardiopulm Rehabil. 2004 Jul-Aug;24(4):236-44. doi: 10.1097/00008483-200407000-00005.

    PubMed 15286528

  • Messier SP, Royer TD, Craven TE, O'Toole ML, Burns R, Ettinger WH Jr. Long-term exercise and its effect on balance in older, osteoarthritic adults: results from the Fitness, Arthritis, and Seniors Trial (FAST). J Am Geriatr Soc. 2000 Feb;48(2):131-8. doi: 10.1111/j.1532-5415.2000.tb03903.x.

    PubMed 10682941

  • Ades PA, Ballor DL, Ashikaga T, Utton JL, Nair KS. Weight training improves walking endurance in healthy elderly persons. Ann Intern Med. 1996 Mar 15;124(6):568-72. doi: 10.7326/0003-4819-124-6-199603150-00005.

    PubMed 8597320

  • Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.

    PubMed 21825283

  • Pahor M, Guralnik JM, Ambrosius WT, Blair S, Bonds DE, Church TS, Espeland MA, Fielding RA, Gill TM, Groessl EJ, King AC, Kritchevsky SB, Manini TM, McDermott MM, Miller ME, Newman AB, Rejeski WJ, Sink KM, Williamson JD; LIFE study investigators. Effect of structured physical activity on prevention of major mobility disability in older adults: the LIFE study randomized clinical trial. JAMA. 2014 Jun 18;311(23):2387-96. doi: 10.1001/jama.2014.5616.

    PubMed 24866862

  • Teng EL, Chui HC. The Modified Mini-Mental State (3MS) examination. J Clin Psychiatry. 1987 Aug;48(8):314-8.

    PubMed 3611032

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention and Healthy Aging Intervention in people with Mobility Limitation, run by Tufts University at 2 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 9 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

This study will assess the safety of translating LIFE PA to a real-world community based setting by monitoring the occurrence of adverse events and serious adverse events. (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT03430271, which also lists 27 linked publications.

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 14 Feb 2018.

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