Active for Life Assisted Living Feasibility and Acceptability Study

NCT ID: NCT04386434

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2020-12-31

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.

Detailed Description

Sedentary behavior (SB) is an emerging health risk, especially for older adults, as it is associated with chronic disease, loss of function, and increased disability and frailty. Older adults in assisted living (AL) are less active than their peers living independently. Recent evidence demonstrates there are substantial health benefits from light physical activity (LPA) and the newly published Physical Activity Guidelines for Americans recommends that older adults replace SB with LPA. An intervention to increase LPA and reduce SB has potential to reduce health risks, slow functional decline and frailty, and delay residents' needs for higher-level care such as a nursing home. We propose to test the feasibility and acceptability of a self-efficacy based intervention, "Active for Life," with the goal of increasing PA and decreasing SB of AL residents.

Active for Life is a 12 week intervention. Key components include (a) exercise with functional circuit training (FCT), walking, and stretching, (b) a behavioral component with a structured self-efficacy enhancing intervention that includes self-regulation strategies, and (c) education that addresses principles of exercise, the distinct health benefits of LPA, the negative consequences of too much sedentary time, and strategies for overcoming barriers to physical activity. It is important to test the feasibility and acceptability of the intervention for AL residents because this population will be more frail than previously tested populations. The intervention has been modified to be appropriate for AL residents based on guidance from AL experts and individual interviews conducted with AL residents. We will enroll 27 participants from approximately four AL facilities. Outcomes will be measured at baseline and at conclusion of the intervention. The primary outcomes are feasibility and acceptability of the intervention, but we will also examine preliminary evidence of outcome measures of objectively-measured sedentary behavior and physical activity, self-efficacy for exercise, value of physical activity, self-rated health, physical function, anxiety, depression, pain interference, and fatigue. This study is innovative because there are no well-established evidence-based interventions to promote PA in the AL setting and none that focus on increasing LPA and decreasing SB.

Conditions

Sedentary Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Active for Life

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

Group Type: EXPERIMENTAL

Active for Life: Assisted Living

Intervention Type: 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.

Interventions

Active for Life: Assisted Living

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Janet L. Larson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janet L Larson, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Nursing

Locations

University of Michigan School of Nursing

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00175558

Identifier Type: -

Identifier Source: org_study_id