Community-based Intervention Effects on Older Adults' Physical Activity

Physical Activity Clinical Trial

Official title:

Community-based Intervention Effects on Older Adults' Physical Activity and Falls (R01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326141
• Other study ID #: 1607S90922
• Secondary ID: 1R01NR016705-01A
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research team will conduct a 2 x 2 factorial experiment testing the individual and combined effects of two empirically and theoretically relevant sets of behavior change strategies on community-dwelling older adults' physical activity. To do this the investigators will randomize participants >= 70 years old (n = 308) to 1 of 4 experimental conditions. All conditions include an evidence-based physical activity protocol endorsed by Centers for Disease Control and Prevention (CDC) for use by all older adults, including those with frailty and multiple co-morbidities and the commercially available physical activity monitor (e.g., Fitbit) to augment intervention delivery. Intervention components that are experimental and vary by condition are the sets of behavior change strategies which will be combined with the physical activity protocol and the physical activity monitor. Condition 1 has no specific behavior change strategies; Condition 2 includes an intervention component comprised of 5 interpersonal behavior change strategies, such as facilitating social support and social comparison; Condition 3 includes an intervention component comprised of 5 intrapersonal behavior change strategies, such as setting personally meaningful goals; and Condition 4 includes both sets of behavior change strategies -- 5 interpersonal strategies combined with 5 intrapersonal behavior change strategies.

Description:

To fully examine the effects of these experimental components, The investigators have delineated Primary, Secondary and Exploratory Aims:

Primary Aim: Determine which experimental intervention component(s) increase PA among community-dwelling older adults post-intervention: immediately, 6 months, and 12 months. Hypothesis: Participants receiving the interpersonal set of behavior change strategies (conditions 2 and 4) will have clinically meaningful increases in PA post- intervention (at all 3 time-points), compared to participants not receiving these strategies (conditions 1 and 3).

Secondary Aim: Determine which experimental intervention component(s)decrease fall occurrence and increase quality of life (QOL) among community-dwelling older adults 12 months post-intervention. Hypotheses: Participants receiving the set of interpersonal behavior change strategies will have clinically meaningful reductions in falls and increases in QOL, 12 months post-intervention, compared to participants not receiving these strategies.

Exploratory Aim: Evaluate experimental intervention component effects on targeted psychosocial constructs (social support; readiness; self-regulation) and physical constructs (functional leg strength and balance), which are theorized as mechanisms of change--and whether these mechanisms mediate the effects of experimental intervention components on PA and falls. Hypotheses: Receiving the interpersonal behavioral change strategies, relative to not receiving these strategies, will elicit increases in targeted psychosocial constructs and increases in physical constructs, which in turn will mediate the intervention's effects on PA behavior and falls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• =70 years of age

• English speaking

• Low levels of PA (below recommended guidelines)

• Self-reported fall risk as guided by the CDC, Steadi fall risk screener

• One or more falls in the last year

• Unsteadiness when standing or walking

• Worries about falling

• Participants who self-report the following symptoms will require clearance from a primary provider (as guided by the Exercise and Screening for You Questionnaire)

• Pain, tightness or pressure in chest during PA (walking, climbing stairs, household chores, similar activities) that have not been checked and/ or treated by a healthcare provider

• Current dizziness that have not been checked and/ or treated by a healthcare provider

• Current, frequent falls that have not been checked and/ or treated by a healthcare provider

Exclusion Criteria:

• Lower extremity injury or surgery within the past 6 weeks

• Inability to walk

• Formal diagnosis of neurocognitive impairment or dementia

Related Conditions & MeSH terms

• Accidental Fall
• Exercise
• Motivation
• Older Adults
• Physical Activity

Intervention

Behavioral:
• Otago Exercise Program
The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.

Device:
• Physical activity monitors (e.g., Fitbit)
We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.

Behavioral:
• Interpersonal Behavior Change Strategies
The interpersonal content will include facilitated discussed about including PA into social routines, identifying and problem-solving social and environmental barriers to PA, social support for exercise, and friendly social comparisons about practicing PA outside the small group setting and interpreting/ sharing data.
• Intrapersonal Behavior Change Strategies
The intrapersonal content will include encouragement and guidance to identify baseline PA patterns, develop and refine personally meaningful goals and plans, identify and problem solve personal barriers to staying physically active, integrate PA into personal routines, and monitor goal outcomes

Other:
• Information about Health and Wellness
Information about health and wellness varies in dose, according to time spent in each condition that addresses behavior change. Topics in condition 1 include sleep, vaccinations, supplements, fall risk factors, memory, hearing and pain guided by information for older adults available on the NIA and CDC websites. Topics in conditions 2 and 3 include fall risk factors and sleep. Topics in condition 4 include fall risk factors.

Locations

Country	Name	City	State
United States	University of Minnesota - School of Nursing	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of Physical Activity Measured Objectively	Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)	Baseline and Post-Intervention (one week, six months, twelve months)
Primary	Physical Activity Scale for the Elderly (PASE)	Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.	Baseline and Post-Intervention (one week, six months, twelve months)
Secondary	Fall Rate	Falls per person year, assessed via prospective monthly calendars	12 months post intervention
Secondary	Number of Participants With Moderate or Major Injuries From Falls	Number of injuries from falls was measured via prospective falls calendars mailed to participants monthly with return addressed/stamped envelopes. Circumstances and injuries related to each fall were documented on the calendars. Calendar documentation each fall was verified and detailed through phone conversations between participants and trained research staff. Moderate and Major injuries from falls were categorized according to the Agency for Healthcare Research and Quality with moderate injuries defined as necessitating sutures, skin glue, splinting, and or involving muscle or joint strain. Major injuries were defined as those associated with internal injuries or a need for surgery, casting, traction, or neurological consults.	12 months post intervention
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health	Using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire 1.2. Two constructs from this questionnaire were converted to t scores: self-reported physical health and self-reported mental health. . Mean t scores are 50, which indicates the adult population mean with a standard deviation of 10. Higher t scores are considered better, or healthier, for self-reported physical health and mental health.; No clinically relevant thresholds were described in this study.	Baseline and post-intervention: one-week, six months, and 12 months