NCT04037436: MoveStrong

Functional Exercise and Nutrition Education Program for Older Adults

Completed NA Results posted Last updated 13 April 2025

What this trial tests

NA trial testing Strength and Balance Training & Nutrition Education in Chronic Disease in 44 participants. Completed in 1 September 2020.

Timeline

24 September 2019

Primary endpoint
14 March 2020

1 September 2020

Quick facts

Lead sponsor	University of Waterloo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	44
Start date	24 September 2019
Primary completion	14 March 2020
Estimated completion	1 September 2020
Sites	5 locations across Canada

Drugs / interventions tested

• Strength and Balance Training & Nutrition Education
• Usual Care

Conditions studied

• Chronic Disease — all drugs for Chronic Disease →
• Frail — all drugs for Frail →
• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Cancer — all drugs for Cancer →

Sponsor

University of Waterloo

Who can join

60 and older, any sex, with Chronic Disease or Frail. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility - Recruitment Primary · 2 month (September to October 2019)

Definition: Number recruited at end of rollout. The criterion for success is to recruit 10 participants at each of 4 sites.

Group	Value	95% CI
Arbour Trails	9
City of Lakes Family Health Team	15
Village of Winston Park	9
YMCA's	11

Feasibility - Retention Primary · Start of the program to 9 weeks

Definition: Number retrained at post-rollout end. The criterion for success is 90% at rollout end.

Group	Value	95% CI
Arbour Trails	6
City of Lakes Family Health Team	8
Village of Winston Park	8
YMCA's	9

Feasibility - Adherence Primary · 16 sessions

Definition: Percentage of individuals that attended exercise and nutrition sessions. The criterion for success is 70% or higher.

Group	Value	95% CI
Arbour Trails	73	62.7 – 81.6
Kinnect to Wellness	66	45.5 – 77.5
Winston Park	73	61.5 – 82.5
YMCA	77	72 – 84.5

Body Weight Secondary · Baseline

We will measure body weight with a calibrated scale.

Group	Value	95% CI
Arbour Trails	63.96	± 12.27
Kinnect to Wellness	77.09	± 10.39
Winston Park	64.76	± 7.63
YMCA	66.66	± 12.80

10 Meter Walk Test Secondary · Mean change from follow up (study visit 4) and baseline

Fried Frailty Index Components: walking speed via the 10-meter walk test protocol.

Group	Value	95% CI
Arbour Trails	0.08	± 0.17
Kinnect to Wellness	0.16	± 0.24
Winston Park	0.31	± 0.36
YMCA	0.16	± 0.23

Grip Strength Secondary · Mean change from follow up (study visit 4) and baseline

Fried Frailty Index Components: weakness via the Jamar hand-held dynamometer

Group	Value	95% CI
Arbour Trails	0.17	± 4.31
Kinnect to Wellness	-1.57	± 6.24
Winston Park	0.89	± 0.33
YMCA	0.86	± 6.26

30 Second Chair Stand Test Secondary · Mean change from follow up (study visit 4) and baseline

We will use a chair with a straight back without arm rests (seat 17" high), and a stopwatch. This will assess leg strength and endurance.

Group	Value	95% CI
Arbour Trails	1.33	± 2.69
Kinnect to Wellness	2.44	± 2.53
Winston Park	2.04	± 2.45
YMCA	0.64	± 9.29

4 Square Step Test Secondary · Mean change from follow up (study visit 4) and baseline

The Four Square Step Test is used to assess dynamic stability and the ability of the subject to step over low objects forward, sideways, and backward. For older adults \> 15 seconds indicates increased risk of falls

Group	Value	95% CI
Arbour Trails	-5.14	± 6.48
Kinnect to Wellness	6.54	± 6.15
Winston Park	5.39	± 6.54
YMCA	-1.86	± 3.03

EuroQol 5 Dimension Version 5-level (EQ-5D-5L) Secondary · Mean change from follow up (study visit 4) and baseline

The EuroQol 5 dimension version 5-level (EQ-5D-5L) measures quality of life using 5 dimensions, on a 5 point scale, where a higher point is considered better. The scores on the subscales are given weights and summed to convert the scores to one index score. The range of possible scores for the EQ-5D-5L index is from -0.573 to 1. A higher score is better.

Group	Value	95% CI
Arbour Trails	0.04	± 0.08
Kinnect to Wellness	0.06	± 0.08
Winston Park	0.25	± 0.33
YMCA	0.06	± 0.07

Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool Secondary · Mean change from follow up (study visit 4) and baseline

We will use the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to conduct interviewer administered diet recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to quantify and compare protein and energy intakes at baseline and follow-up only. There is no scale to this section

Group	Value	95% CI
Baseline	69.46	69.46 – 22.29
Follow-up	70.88	54.80 – 77.00

Number of Participants With Adverse Events Secondary · Study visit 1, 2, 3 and 4

We will ask participants to report adverse events and falls, using Health Canada definitions. We will report serious and non-serious adverse events (total and attributable to intervention). There is no scale to this section

Group	Value	95% CI
Arbour Trails	1
Kinnect to Wellness	1
Winston Park	2
YMCAs	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Over 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 1/44 (2%)

Deaths: 0

Control

Serious: 2/44 (5%)

Deaths: 0

Serious adverse events (1 terms)

Reaction	System	Intervention	Control
Intervention	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Intervention	Control
Cardio	Cardiac disorders	—	—

Most-reported serious reactions: Intervention.

Data from ClinicalTrials.gov NCT04037436 adverse events section.

Sponsor's own description

There is strong evidence that specific types of exercise can improve health and physical function in older adults. While community exercise classes exist, many older adults with chronic conditions may need guidance from credentialed exercise professionals to ensure sufficient dose and progression and to address fears or low exercise self-efficacy. Furthermore, low protein intake among older adults is common and initiating exercise when nutrition is inadequate may cause weight loss and limit gains in muscle strength. The primary goal is to determine the feasibility of implementing the MoveSTroNg program under real-world conditions, measured through referral and recruitment to the program and study retention and adherence rates.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The MoveStrong program for promoting balance and functional strength training and adequate protein intake in pre-frail older adults: A pilot randomized controlled trial.
   Rodrigues IB, Wang E, Keller H, Thabane L, et al · · 2021 · cited 10× · PMID 34559837 · DOI 10.1371/journal.pone.0257742
2. Encouraging older adults with pre-frailty and frailty to "MoveStrong": an analysis of secondary outcomes for a pilot randomized controlled trial.
   Rodrigues IB, Wagler JB, Keller H, Thabane L, et al · · 2022 · cited 6× · PMID 35766913 · DOI 10.24095/hpcdp.42.6.02