Clinical trial NCT04663685: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Cancer
Cardiovascular Diseases
Chronic Lung Disease
Congestive Heart Failure
Diabetes
Hypertension
Kidney Diseases
Obesity
Osteoporosis
Stroke
Frailty
Keywords: remote delivery
exercise
pre-frail
nutrition
pilot study
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an 8-week feasibility study with a 4-week follow-up. Time series design.

Note: 6-month follow-up was optional and exploratory in nature.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Recruitment
timeFrame: Through study completion, an average of 12 weeks
measure: Retention
timeFrame: Through study completion, an average of 12 weeks
measure: Average Adherence to Nutrition Sessions
timeFrame: Through study completion, an average of 12 weeks
measure: Average Adherence to Exercise Sessions
timeFrame: Through study completion, an average of 12 weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: Baseline, week 9, week 12
measure: Exercise Self-efficacy Scale
timeFrame: Baseline, week 9, week 12
measure: 30-second Chair Stand
timeFrame: Baseline, week 9, week 12
measure: Static Balance
timeFrame: Baseline, week 9, week 12
measure: Fatigue
timeFrame: Baseline, week 9, week 12
measure: Mental Health and Social Isolation
timeFrame: Baseline, week 9, week 12
measure: Quality of Life Score
timeFrame: Baseline, week 9, week 12
measure: Nutritional Risk
timeFrame: Baseline, week 9, week 12
measure: Dietary Protein Intake
timeFrame: Baseline, week 9, week 12
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo
Study officials:
affiliation: University of Waterloo
name: Lora Giangregorio, PhD
role: PRINCIPAL_INVESTIGATOR
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