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.

NCT ID: NCT04663685

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2021-10-12

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.

Conditions

Arthritis; Cancer; Cardiovascular Diseases; Chronic Lung Disease; Congestive Heart Failure; Diabetes; Hypertension; Kidney Diseases; Obesity; Osteoporosis; Stroke; Frailty

Study Design

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

Study Groups

Single Arm

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.

Group Type: EXPERIMENTAL

Exercise program

Intervention Type: OTHER

Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift \& carry and calf raise.

Nutrition education

Intervention Type: OTHER

Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q\&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.

Interventions

Exercise program

Participants received two 1-on-1 exercise sessions per week to start. Each session lasted 30 minutes. As progress was made, participants were encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises were aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift \& carry and calf raise.

Intervention Type: OTHER

Nutrition education

Participants received a nutrition education booklet and had access to five online videos that correspond to key topics in the booklet (reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day). Participants attended three 60-minute nutrition Q\&A sessions led by a dietitian, where the group reviewed content from the booklet and videos, and discussed personalized strategies to increase protein intake.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lora Giangregorio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

University of Waterloo

Waterloo, , Canada

Countries

Canada

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

42206

Identifier Type: -

Identifier Source: org_study_id