Age 65 and OlderNCT02337803
Band Together: Randomized Control Trial
A study testing Strength Training Program in people with Age 65 and Older and Strength Training, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age 65 and Older, Strength Training
- What is being tested?
- Strength Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Aug 2015
- 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
- Fluently read and speak English
- Willing to drive 3 times a week to Hershey Medical Center for most weeks
- Have a primary care physician
- Currently exercise ≤60 min per week
Who cannot join
- Doctor has said you have a heart condition and should only do physical activity recommended by doctor
- Feel pain in chest when doing physical activity
- Unable to obtain doctor's consent
- Currently participating in an exercise program
- Plans to move in the next 6 months
- Weight > 250
- Currently exercise ≥60 min per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old
Read the detailed description
Older adults in the US are in a difficult situation that is historically unprecedented. People born in 1930 were expected to live to age 59, yet they will live to an average age of 79. These dramatic survival increases, due to immunizations, antibiotics and other innovations [Centers for Disease, 2011], have occurred at the same time as dramatic reductions in daily energy expenditures, due to automobiles, washing machines and other labor-saving devices [Archer, 2013]. This has left adults living longer, yet weaker, less fit and more obese. In fact, most residents of nursing homes are not there because of dementia. Only 40% of long-term care facility residents in 2010 were diagnosed with dementia [Caffrey, 2012] and many of whom had a level of dementia which would not require nursing home placement by itself. Most residents of long-term care facilities, rather, are there because they lack the strength and fitness to care for themselves. As baby boomers retire, these factors are anticipated to greatly increase the need for long-term care, highlighted in a report from a Deloitte Consulting in 2010: "Medicaid Long-term Care: The ticking time bomb" [Keckley, 2010]. This pilot study will measure a significant increase in strength with the use of a 12 week strength training program.
- Conditions
- Age 65 and Older, Strength Training
- Being tested
- Strength Training Program, Usual Care
- Keywords
- Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Training ProgramBehavioural
The strength training program consists of 6 exercises using resistance bands three times a week
Usual CareBehavioural
Will continue daily physical activity and complete surveys online
| Study group | Role | What they receive |
|---|---|---|
| Strength Training Group | Experimental | Participants will meet three times a week for one hour strength training sessions for twelve weeks. Receives: Behavioral: Strength Training Program; Behavioral: Usual Care |
| Usual Care | Active comparator | Participants will be given access to the strength training program after the twelve week study ends. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Repetition Maximum
Measured: 12 weeks
Secondary outcomes (2)
Bow and Arrow Strength Test
Measured: 12 weeks
Hand Grip Test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: A similar study was funded by PCORI so PI decided to not begin this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age 65 and OlderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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, Milton S. Hershey Medical Center
- Investigators
- Christopher Sciamanna, MD, MPH, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337803
- Sponsor's protocol ID
- IRB1056
- Status last verified
- Oct 2017
- First submitted
- 8 Jan 2015
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Band Together: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02337803
- Acronym / sponsor ID
- IRB1056
- Conditions
- Age 65 and Older, Strength Training
- Keywords
- Physical Activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A similar study was funded by PCORI so PI decided to not begin this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Jan 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 study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old
Detailed description
Older adults in the US are in a difficult situation that is historically unprecedented. People born in 1930 were expected to live to age 59, yet they will live to an average age of 79. These dramatic survival increases, due to immunizations, antibiotics and other innovations [Centers for Disease, 2011], have occurred at the same time as dramatic reductions in daily energy expenditures, due to automobiles, washing machines and other labor-saving devices [Archer, 2013]. This has left adults living longer, yet weaker, less fit and more obese. In fact, most residents of nursing homes are not there because of dementia. Only 40% of long-term care facility residents in 2010 were diagnosed with dementia [Caffrey, 2012] and many of whom had a level of dementia which would not require nursing home placement by itself. Most residents of long-term care facilities, rather, are there because they lack the strength and fitness to care for themselves. As baby boomers retire, these factors are anticipated to greatly increase the need for long-term care, highlighted in a report from a Deloitte Consulting in 2010: "Medicaid Long-term Care: The ticking time bomb" [Keckley, 2010]. This pilot study will measure a significant increase in strength with the use of a 12 week strength training program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training Group | Experimental | Behavioral: Strength Training Program, Behavioral: Usual CareParticipants will meet three times a week for one hour strength training sessions for twelve weeks. |
| Usual Care | Active comparator | Behavioral: Usual CareParticipants will be given access to the strength training program after the twelve week study ends. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Fluently read and speak English
- Willing to drive 3 times a week to Hershey Medical Center for most weeks
- Have a primary care physician
- Currently exercise ≤60 min per week
Key exclusion criteria (7 listed)
- Doctor has said you have a heart condition and should only do physical activity recommended by doctor
- Feel pain in chest when doing physical activity
- Unable to obtain doctor's consent
- Currently participating in an exercise program
- Plans to move in the next 6 months
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 |
|---|---|---|
| Strength Training ProgramThe strength training program consists of 6 exercises using resistance bands three times a week | Behavioural | Strength Training Group |
| Usual CareWill continue daily physical activity and complete surveys online | Behavioural | Strength Training Group, Usual Care |
Primary outcome
One Repetition Maximum
Time frame: 12 weeks
2 secondary outcomes
Bow and Arrow Strength Test
Time frame: 12 weeks
Hand Grip Test
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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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.
Christopher Sciamanna, MD, MPH 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 Strength Training Program in people with Age 65 and Older and Strength Training, 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 4 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: withdrawn, as of the sponsor's last update on 13 Oct 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
One Repetition Maximum (time frame: 12 weeks). 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 13 Oct 2017.