Trial Outcomes & Findings for 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 NCT04663685)

NCT ID: NCT04663685

Last Updated: 2024-05-13

Results Overview

The number of participants recruited \>25.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Through study completion, an average of 12 weeks
• Results posted on: 2024-05-13

Participant Flow

Participants were primarily recruited from email or telephone contact lists. In addition, we asked colleagues and collaborators to forward the link to potential participants on their distribution lists. Research support staff and Kinesiologists at two Schlegel Villages and one Luther Villages recruited participants using flyers and word of mouth. The recruitment period went from October 5th, 2020, to December 28th, 2020.

Participant milestones

Measure	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. 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. 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.
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	Single Arm n=30 Participants 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. 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. 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.
Age, Continuous	74 years STANDARD_DEVIATION 7 • n=5 Participants
Sex/Gender, Customized Female	26 participants n=5 Participants
Sex/Gender, Customized Male	4 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	29 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	1 Participants n=5 Participants
Region of Enrollment Canada	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 12 weeks

The number of participants recruited >25.

Outcome measures

Measure

Single Arm n=30 Participants 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. 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. 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.

Recruitment

30 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 12 weeks

Population: 2 participants withdrew from the intervention.

Feasibility threshold: The number of participants retained at follow-up >80%.

Outcome measures

Measure

Single Arm n=30 Participants 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. 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. 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.

Retention

28 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 12 weeks

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure

Single Arm n=3 sessions 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. 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. 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.

Average Adherence to Nutrition Sessions

2.5 sessions Standard Deviation 0.5

PRIMARY outcome

Timeframe: Through study completion, an average of 12 weeks

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure

Single Arm n=36 number of sessions 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. 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. 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.

Average Adherence to Exercise Sessions

30.2 sessions Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Physical Activity Baseline	180 weekly minutes of physical activity Standard Deviation 82
Physical Activity End of the study	310 weekly minutes of physical activity Standard Deviation 85
Physical Activity Follow-up	263 weekly minutes of physical activity Standard Deviation 71

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Exercise Self-efficacy Scale Baseline	26.4 score on a scale of 11-55 Standard Deviation 5.2
Exercise Self-efficacy Scale End of the study	33.6 score on a scale of 11-55 Standard Deviation 5.3
Exercise Self-efficacy Scale Follow-up	35.0 score on a scale of 11-55 Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
30-second Chair Stand Baseline	8.00 number of chair stands completed in 30s Standard Deviation 2.41
30-second Chair Stand End of study	11.50 number of chair stands completed in 30s Standard Deviation 2.72
30-second Chair Stand Follow-up	12.54 number of chair stands completed in 30s Standard Deviation 2.81

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Static Balance Baseline	3.54 score on a scale Standard Deviation 0.39
Static Balance End of study	3.64 score on a scale Standard Deviation 0.39
Static Balance Follow-up	3.82 score on a scale Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Fatigue Baseline	1.86 score on a scale Standard Deviation 0.53
Fatigue End of study	1.07 score on a scale Standard Deviation 0.41
Fatigue Follow-up	1.14 score on a scale Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Mental Health and Social Isolation Baseline	53.5 score on a scale Standard Deviation 3.4
Mental Health and Social Isolation End of study	54.8 score on a scale Standard Deviation 3.0
Mental Health and Social Isolation Follow-up	53.5 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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)

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Quality of Life Score Baseline	0.832 index value/scores on a scale Standard Deviation 0.024
Quality of Life Score End of study	0.805 index value/scores on a scale Standard Deviation 0.034
Quality of Life Score Follow-up	0.807 index value/scores on a scale Standard Deviation 0.038

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Nutritional Risk Baseline	30.9 score on a scale Standard Deviation 2.5
Nutritional Risk End of study	40.3 score on a scale Standard Deviation 2.7
Nutritional Risk Follow-up	38.8 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline, week 9, week 12

Population: 2 participants withdrew from the intervention.

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.

Outcome measures

Measure	Single Arm n=28 Participants 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. 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. 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.
Dietary Protein Intake Baseline	79.8 grams of dietary protein Standard Deviation 9.6
Dietary Protein Intake End of study	92.7 grams of dietary protein Standard Deviation 11.7
Dietary Protein Intake Follow-up	89.0 grams of dietary protein Standard Deviation 11.5

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Single Arm n=28 participants at risk 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. 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. 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.

Musculoskeletal and connective tissue disorders Non-serious, non-attributed

17.9% 5/28 • Number of events 6 • From baseline to 12 weeks of the intervention Health Canada Definition Public Health Agency of Canada (2018) Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry, Ministry of Health. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/reporting-adverse-reactions-marketed-health-products-guidance-industry.html

Additional Information

Ellen Wang

UBC/Arthritis Research Canada

Phone: 2266980999

Email: ewang@arthritisresearch.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place