Active for Life Assisted Living Feasibility and Acceptability Study

NCT04386434 | Withdrawn

• 1 other identifier: HUM00175558
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the effects of a physical activity and behavioral program, called Active for Life, to promote increased physical activity and reduced sedentary behavior of older adults who live in assisted living. A sedentary lifestyle is very common in this population and if this program is successful it will be used to promote physical activity and improve the health of older adults in assisted living.

Conditions

Sedentary Behavior

Keywords

assisted living; physical activity; sedentary behavior; self-efficacy

Outcome Measures

Primary Outcomes (13)

• Feasibility: Number of participants screened

  Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants volunteered to be screened for participation in the study.

  After completion of the 12 week intervention

• Feasibility: Number of participants eligible

  Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants met eligibility criteria for study participation.

  After completion of the 12 week intervention

• Feasibility: Numbers of participants ineligible by each eligibility criterion

  Several measures will be used to describe the feasibility of the intervention. We will summarize reasons that participants were ineligible for study participation by adding up the number of people who don't meet each specific eligibility criterion.

  After completion of the 12 week intervention

• Feasibility: Number of participants who enroll

  Several measures will be used to describe the feasibility of the intervention. We will calculate how many eligible participants decide to enroll in the study.

  After completion of the 12 week intervention

• Feasibility: Length of time for recruitment activities

  Several measures will be used to describe the feasibility of the intervention. We will calculate how much time is spent to recruit the study sample.

  After completion of the 12 week intervention

• Feasibility: Percentage of activity sessions attended by participants

  Several measures will be used to describe the feasibility of the intervention. We will calculate the percentage of activity sessions that participants attended.

  After completion of the 12 week intervention

• Feasibility: Participant retention rates

  Several measures will be used to describe the feasibility of the intervention. We will calculate retention rates of how many participants started and how many completed the study.

  After completion of the 12 week intervention

• Feasibility: Documentation of stated reasons for participant dropout

  Several measures will be used to describe the feasibility of the intervention. We will document stated reasons for dropout from the study as much as we are able.

  After completion of the 12 week intervention

• Feasibility: Injuries and adverse events

  Several measures will be used to describe the feasibility of the intervention. We will summarize any adverse events/injuries that occur during the study.

  After completion of the 12 week intervention

• Feasibility: Rates of missing or unusable data

  Several measures will be used to describe the feasibility of the intervention. We will summarize how much data are missing from baseline, mid-intervention, and post-intervention data collections.

  After completion of the 12 week intervention

• Feasibility: Time required to complete outcome measures

  Several measures will be used to describe the feasibility of the intervention. We will keep record of how long each data collection session takes and calculate average length of data collection at both baseline and post-intervention.

  After completion of the 12 week intervention

• Acceptability: Exit interviews

  Semi-structured exit interviews will ask questions related to acceptability of the intervention, such as how participants felt about the overall intervention and its specific components, whether the time commitment was reasonable, whether assisted living staff were supportive of their participation and goals, and any suggestions for future improvements.

  After completion of the 12 week intervention

• Acceptability: Final acceptability scale

  This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components. Higher score indicates greater intervention acceptability.

  After completion of the 12 week intervention

Secondary Outcomes (11)

• Time spent in sedentary behavior and physical activity

  7 days of data are gathered at baseline at after the 12 week intervention.

• Self-efficacy for exercise

  Measured at baseline, three weeks, and after 12 week intervention.

• Value of Physical Activity

  Measured at baseline and after 12 week intervention.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health

  Measured at baseline and after 12 week intervention.

• PROMIS Physical Functioning

  Measured at baseline and after 12 week intervention.

Study Arms (1)

Active for Life

EXPERIMENTAL

The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

Behavioral: Active for Life: Assisted Living

Interventions

Active for Life: Assisted Living BEHAVIORAL

Each intervention session will take place within the assisted living facility twice a week for 12 weeks. Sessions will begin with 5-10 minutes of walking in the hallway. Participants will be encouraged to walk at their own pace and allowed to take breaks if needed. Next, behavioral strategies based on the construct of self-efficacy from social cognitive theory and education about physical activity will be delivered. This component is scheduled between the walking and circuit training, lasts 15-20 minutes, and serves as a rest period. Circuit training will focus on strength and balance. Approximately 8 exercise stations will be set up, and the exercises performed at each station will be changed approximately every 4 weeks. The circuit training will last \~30-40 minutes, with participants moving from one station to the next at their own pace and taking breaks in between.

Active for Life

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residing in assisted living facility
• Inactive (performing moderate level activities for less than 30 min./day, 5 day/week or not performing muscle strengthening activities twice/week) or a desire to increase physical activity
• Score of at least 3 on the Mini-Cog cognitive screening

You may not qualify if:

• Mobility issues that prevent participation in PA, such as if they rely on a wheelchair or motorized scooter (not excluded if they require an assistive device such as a cane or walker)
• Hospitalization in the previous month
• Skin on the thigh where ActivPAL monitor would be placed is not intact (has lesions, signs of infection, rash, or skin breakdown)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Nursing

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Janet L Larson, PhD, RN

  University of Michigan School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 13, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 28, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)