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Clinical Trial 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. In older adults at risk of mobility impairment, exercise greatly reduced incidence and effects did not vary by frailty status. 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 will be 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 seminars and support groups over Microsoft® Teams. The primary aim of this study is to assess feasibility as determined by recruitment (≥ 25 people in 3 months), retention (≥80%), adherence of (70%) and participant experience.


Clinical Trial Description

MoveStrong at Home is an 8-week pilot study with a 4-week follow up and a 6-month follow up. The primary research question pertains to the feasibility of implementation, defined by recruitment (number of participants recruited at the end of rollout), retention (number retained at post-rollout end), and adherence (percentage of exercise sessions completed) and participant experience. The criteria for success of this study are to recruit 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 will assess 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 will be 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 will be 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 will be used to capture participant experience and identify barriers and facilitators to implementation. The investigators will monitor falls and adverse events throughout the study. The investigators will recruit participants in two phases. The investigators will recruit up to 8 participants between October 5th and October 23rd, 2020 to begin the intervention together by November 2020. Participants recruited after that date will participate in screening and assessments between November 2020 and January 2021, and begin the intervention in January 2021. The investigators will consider making modifications to the protocol to address any challenges that arise during delivery with the first phase of participants. The a priori criteria for success related to recruitment is 25 participants in 3 months or approximately 8 per month. Investigators will overrecruit by 5 participants to account for possible dropouts. Each participant will begin the intervention with two 1-on-1 sessions on non-consecutive days (Monday to Friday) and complete the third session on their own. As progress is made, participants will continue to receive a 1-on-1 session each week and complete two sessions independently. Participants may request to keep both private sessions if they are attending by telephone or require additional assistance. If a participant is unable to attend a 1-on-1 session due to a prior commitment, illness, or injury, a make-up session will be scheduled for the same week or following week as necessary. An optional group session that focuses on behaviour change techniques will take place on weeks 3, 5 & 7 (Wednesday). The intention is to foster a sense of community and allow participants to share their experiences with one another. These sessions do not count toward adherence. In addition, individuals will participate in three dietitian-led virtual group seminars to review content from the booklet and videos, as well as discuss more personalized strategies to increase protein intake. The dietitian will consider 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) will occur on weeks 2, 4, and 6 (Wednesday). In total, the dietitian will host 9-12 seminars split between the two phases. The long-term goal of the investigators is not to test the efficacy of exercise, but to evaluate the implementation of scalable and sustainable models to promote exercise at home or in the community. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04663685
Study type Interventional
Source University of Waterloo
Contact
Status Active, not recruiting
Phase N/A
Start date October 5, 2020
Completion date October 12, 2021

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