Band Together: Randomized Control Trial

The study will aim to determine the effectiveness of a strength training program using resistance bands to increase strength in adults ≥65 years old

Study Overview

• Status: Withdrawn
• Conditions: Strength Training; Age 65 and Older
• Intervention / Treatment: Behavioral: Strength Training Program; Behavioral: Usual Care

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength Training Group; Participants will meet three times a week for one hour strength training sessions for twelve weeks.	Behavioral: Strength Training Program; The strength training program consists of 6 exercises using resistance bands three times a week; Behavioral: Usual Care; Will continue daily physical activity and complete surveys online
Active Comparator: Usual Care; Participants will be given access to the strength training program after the twelve week study ends.	Behavioral: Usual Care; Will continue daily physical activity and complete surveys online

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
One Repetition Maximum	12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS)	survey	12 weeks
National Health Interview Surveys	survey	12 weeks
Physical Activity Scale for the Elderly (PASE)	survey	12 weeks
Cognitive Impairment Questionnaire	survey	12 weeks

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 8, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity
• Other Study ID Numbers: IRB1056