Band Together: Randomized Control Trial | NCT02337803

Studies
Band Together: Randomized Control Trial

NCT02337803

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

Oct 13, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Age 65 and Older
Strength Training

Interventions

Strength Training Program
Usual Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

A similar study was funded by PCORI so PI decided to not begin this study.

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jan 8, 2015

First Submission Date that Met QC Criteria

Jan 8, 2015

First Posted Date

Jan 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Sciamanna, MD, MPH, Professor of Medicine and Public Health Sciences; Division Chief of General Internal Medicine, Milton S. Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Strength Training Group	Experimental	Participants will meet three times a week for one hour strength training sessions for twelve weeks.	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.	Behavioral: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strength Training Program	Behavioral	The strength training program consists of 6 exercises using resistance bands three times a week	Strength Training Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One Repetition Maximum		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Bow and Arrow Strength Test		12 weeks
Hand Grip Test		12 weeks

Other Outcomes

Measure	Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS)	survey	12 weeks
National Health Interview Surveys	survey	12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher Sciamanna, MD, MPH	Milton S. Hershey Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State College of Medicine, Penn State Hershey Medical Center		Hershey	Pennsylvania	17033	United States

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided