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.

November 30, 2023 updated by: University of Waterloo
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Waterloo, Canada
        • University of Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: Through study completion, an average of 12 weeks
The number of participants recruited >25.
Through study completion, an average of 12 weeks
Retention
Time Frame: Through study completion, an average of 12 weeks
Feasibility threshold: The number of participants retained at follow-up >80%.
Through study completion, an average of 12 weeks
Average Adherence to Nutrition Sessions
Time Frame: 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.
Through study completion, an average of 12 weeks
Average Adherence to Exercise Sessions
Time Frame: 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.
Through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 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.
Baseline, week 9, week 12
Exercise Self-efficacy Scale
Time Frame: 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.
Baseline, week 9, week 12
30-second Chair Stand
Time Frame: 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.
Baseline, week 9, week 12
Static Balance
Time Frame: 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.
Baseline, week 9, week 12
Fatigue
Time Frame: 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.
Baseline, week 9, week 12
Mental Health and Social Isolation
Time Frame: 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.
Baseline, week 9, week 12
Quality of Life Score
Time Frame: 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)
Baseline, week 9, week 12
Nutritional Risk
Time Frame: 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.
Baseline, week 9, week 12
Dietary Protein Intake
Time Frame: 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.
Baseline, week 9, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Waterloo

Investigators

  • Principal Investigator: Lora Giangregorio, PhD, University of Waterloo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

April 9, 2021

Study Completion (Actual)

October 12, 2021

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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