MoveStrong at Home: A Feasibility Study of a Model for Remote Delivery of Functional Strength and Balance Training Combined With Nutrition Education for Older Pre-frail Adults.

Not Applicable

Completed

Conditions: Chronic Lung Disease
Osteoporosis
Frailty
Cardiovascular Diseases
Stroke
Cancer
Congestive Heart Failure
Hypertension
Diabetes
Kidney Diseases

Interventions: Other: Exercise program
Other: Nutrition education

Registration Number: NCT04663685

Lead Sponsor: University of Waterloo

Brief Summary: Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong was delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition Q\&A sessions and group discussion sessions over Microsoft® Teams. The primary aim of this study was to assess feasibility and acceptability of a remote model as determined by recruitment (≥ 25 people in 3 months), retention (≥80%), adherence of (70%) and participant experience.

Detailed Description: MoveStrong at Home is an 8-week pilot study with a 4-week follow-up.

The primary research question pertains to the feasibility of implementation, defined by recruitment (number of participants recruited), retention (number retained at follow up), and adherence (percentage of exercise and nutrition sessions completed) and participant experience. The criteria for success included recruitment of 8 participants per month (up to a total of 25 participants in 3 months), retention of ≥80% at follow-up, and adherence of ≥70% across all exercise and nutrition sessions.

For secondary outcomes, the investigators assessed the effects of MoveStrong at Home on physical activity, fatigue, mental health and social isolation, quality of life, as well as protein/energy intake via telephone at baseline, post intervention and at follow-up. The following questionnaires were used: Physical Activity Scale for the Elderly; Centre for Epidemiologic Studies Depression Scale-fatigue questions; Warwick-Edinburgh Mental Well-being Scale; EQ5D5L20; and the Automated Self-Administered 24-Hour Dietary Assessment Tool (via interview). Physical function was assessed at baseline, post intervention and at follow-up using adapted and self-administered versions of the Short Performance Physical Battery balance test and the 30-second chair stand test. Qualitative exit and follow-up interviews were used to capture participant experience and identify barriers and facilitators to implementation and maintenance. The investigators monitored falls and adverse events throughout the study.

The investigators recruited participants in two phases. The investigators recruited 9 participants between October 5th and October 23rd, 2020 to begin the intervention together by November 2020. Participants recruited after that date participated in screening and assessments between November 2020 and January 2021, and began the intervention in January 2021. The investigators considered making modifications to the protocol to address any challenges that arose during delivery with the first phase of participants. Investigators over recruited by 5 participants to account for possible dropouts.

Each participant started the intervention with two 1-on-1 sessions on non-consecutive days (Monday to Friday) and completed the third session on their own. As progress is made, participants continued to receive a 1-on-1 session each week and completed two sessions independently. If a participant was unable to attend a 1-on-1 session due to a prior commitment, illness, or injury, a make-up session was scheduled for the same week or following week as necessary.

In addition, individuals participated in three dietitian-led virtual group Q\&A sessions to review content from the booklet and videos, as well as discuss more personalized strategies to increase protein intake. The dietitian considered the cost of preparing high-protein foods and the accessibility of these foods during a time of physical distancing. 60-minute small group seminars (5-10 participants) occurred on weeks 2, 4, and 6 (Wednesday).

An optional group discussion session that focused on behaviour change techniques took place on weeks 3, 5 \& 7 (Wednesday). The intention was to foster a sense of community and allow participants to share their experiences with one another. These sessions did not count toward adherence.

The goal of the investigators was not to test the efficacy of exercise, but to evaluate the implementation of a scalable and sustainable models to promote exercise at home or in the community.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Has at least one of the following chronic conditions: arthritis, cancer (other than minor skin cancer), cardiovascular disease, chronic lung disease, congestive heart failure, diabetes, hypertension, kidney disease, obesity, osteoporosis, stroke
Scored ≥ 1 point on the FRAIL Scale
Able to give informed consent

Exclusion Criteria

Current or recent (within the past 6 months)participation in progressive resistance training program ≥ 2 times per week
Receiving palliative care
Unable to perform basic activities of daily living or follow 2-step commands (moderate-severe cognitive impairment)
Upcoming travel plans (travelling> 1 week during the program)
Absolute exercise contraindications (ACSM guidelines)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Nutrition education	This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.
Single Arm	Exercise program	This was the only arm in the study. All participants were allocated to this arm, where they received an 8-week remotely-delivered exercise and nutrition program.

Primary Outcome Measures

Name	Time	Method
Average Adherence to Exercise Sessions	Through study completion, an average of 12 weeks	Participants were encouraged to complete at least 3 exercise sessions per week (one supervised and two independent) for the duration of the intervention (12 weeks). Feasibility threshold: "Attendance" or the average proportion of exercise sessions completed \>70% or 25.3/36 sessions.
Retention	Through study completion, an average of 12 weeks	Feasibility threshold: The number of participants retained at follow-up \>80%.
Recruitment	Through study completion, an average of 12 weeks	The number of participants recruited \>25.
Average Adherence to Nutrition Sessions	Through study completion, an average of 12 weeks	Participants were encouraged to attend 3 nutrition sessions that took place on weeks 2, 4 and 6 of the intervention (12 weeks). Feasibility threshold: "Attendance" or the average proportion of nutrition sessions \>67% or \>2/3 sessions.

Secondary Outcome Measures

Name	Time	Method
30-second Chair Stand	Baseline, week 9, week 12	The 30-second Chair Stand was used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. A higher score on the test indicated a better outcome.
Physical Activity	Baseline, week 9, week 12	A Physical Activity Screen (PAS) was used to capture average minutes of moderate-to-vigorous physical activity each week (Clark et al., 2020). This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results were compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week. A higher score indicated a better outcome.
Static Balance	Baseline, week 9, week 12	Static balance was measured using Short Performance Physical Battery (SPPB) (J. M. Guralnik et al., 1994) balance subscale. The subscale scores ranged from 0-4, with a higher score indicating greater balance. The instructions for this test were adapted for self-administration under the remote supervisor supervision of the exercise physiologist. Please note that the SPPB gait speed and chair stand subscales were not included as a part of the assessment. Therefore the total score for the SPPB (0-12) was not summed.
Fatigue	Baseline, week 9, week 12	Fatigue was assessed using the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) (Radloff, 1977). Only two questions on the CES-D were used: "I felt that everything I did was an effort" and "I could not get going". Scores ranged from of 0-6 and were summed from the two selected questions (lowest response option was "Rarely (\<1 day) = 0", highest response option was "Nearly every day = 3"). Responses closer to the lowest response option indicated a better outcome.
Nutritional Risk	Baseline, week 9, week 12	The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool was used to assess appetite, understand eating habits, and record recent changes in weight. Scores ranged from of 0-64 and were summed from 14 questions (lowest response option was "0", highest response option was "4"). Responses closer to the highest response option indicated a better outcome.
Exercise Self-efficacy Scale	Baseline, week 9, week 12	A modified version of the Exercise Self-Efficacy Scale (ESES) was used to assess levels of planning and execution of exercise related activities (Resnick \& Jenkins, 2000). There were a total of 11 questions. The lowest response option to each question was "Not true at all = 1", while the highest was "Exactly true = 5". Responses closer to the highest response option indicate a better outcome. Overall instrument score ranged from 11-55 points.
Mental Health and Social Isolation	Baseline, week 9, week 12	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) was used to assess positive aspects of mental health. Score ranges from 14-70 and were summed from 14 questions (lowest response option was "None of the time =1", highest response option was "All of the time = 5"). Responses closer to the highest response option indicated a better outcome.
Dietary Protein Intake	Baseline, week 9, week 12	ASA24®-Canada was a guided web-based tool used to record a three 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) were reported to track protein intake (Subar et al., 2012). An average of the three days was then calculated.
Quality of Life Score	Baseline, week 9, week 12	The EuroQol Group 5 Dimension 5 Level (EQ5D5L) questionnaire was used to evaluate health-related quality of life (Herdman et al., 2011). The system comprised five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension had five levels: "no problems = 1" to "extreme problems = 5". Responses with lower scores indicated a better outcome. An index value ranging from 0-1 is then generated from the equation by from the scores of the five domains (Xie et al. 2016)