NCT07011784

Brief Summary

Falls are one of the leading causes of hospitalization and mortality among older adults (aged 65+) in Canada. Falls result from postural instability following age-related declines in muscle strength which begin in the 5th decade of life. Older women have higher rates of injury from falls due to greater deterioration of bone mass density and lower levels of physical activity when compared to men. Participation in physical activity and exercise has been shown to slow these age-related declines in postural stability by improving muscle function as well as proprioceptive and sensory systems, however the majority of older women are inactive. Dance has been used to inspire physical activity uptake among older women, and is particularly good for balance due to its both sensory and motor aspects that focus on precise execution of movement. Dance interventions have been found to improve postural stability and balance confidence. Post-pandemic, online dance classes have provided greater accessibility to exercise interventions aimed at promoting balance. These help reach women facing transportation barriers, who have a fear of exercising with others, women with time-consuming caregiver roles at home etc. While beneficial, the intensity of online classes must be lower to ensure safety, thereby limiting physiological stimulus for adaptations. As typically higher intensity exercise is needed to promote muscle strength there may not be adequate stimulus for adaptations. Furthermore, there is little evidence of strength gains even from in-person dance classes. Blood flow restriction may offer an easy and cost-effective way to mimic higher intensity exercise and boost training benefits. Blood flow restriction has been found to boost strength during low-intensity resistance training, but there is little information on adaptations after balance training or potential transfer to reduce the risk of falls. This 12-week online exercise intervention investigates whether blood flow restriction during dance classes can augment strength, dynamic balance and postural stability of older women aged 65 years and above. Two groups of older women will participate in twice weekly 75 minute ballet and modern-dance classes over Zoom. One group will be randomized to wear 5 centimeter elasticised blood flow restriction bands on their proximal thighs during the classes. Bands will be tightened to a 7/10 of perceived tightness. Postural stability will be assessed using 9, 30-second trials of quiet standing on a force platform in conditions of eyes-open, eyes-closed and on a foam block - trials will be staggered to reduce fatigue effects. Trials will also be video recorded for kinematic analysis of shoulder and hip displacement using Kinovea. Dynamic balance will be assessed using the Star Excursion Balance Test. Participants will be asked to stand on one foot in the middle of the star and reach their other leg as far as they can above the line. The distance the participant reaches in each direction will be recorded and normalized by limb length. Strength will be assessed using the 30-second Sit-to-Stand test and Calf-Raise Senior test. Both tests involve participants doing the maximum number of repetitions possible within a 30-second time frame. Finally scales of fears of falling and overall perceptions of health will be collected. It is expected that this study will have great practical implications as the accessibility of this program can provide opportunities to older adults from various remote locations to increase their levels of physical activity in a safe manner. The affordability may also aid in adoption by community health and recreation centers as an easy-to-implement program that helps to reduce the risk of falls of older women, thereby promoting independence and quality of life.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in distance reached in each direction (from pre-mid-post) on the Star Excursion Balance Test, normalized by limb length

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

  • Change in number of repetitions on the Calf-Raise Senior test from pre-mid-post

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

  • Change in number of repetitions on a 30 second Sit-to-Stand test from pre-mid-post

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

  • Change postural stability during 30 second trials of quiet standing (conditions: eyes open, eyes closed, foam)

    Videos of the quiet standing task will also be recorded for kinematic analysis of shoulder and hip sway using markerless motion capture software.

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

Secondary Outcomes (2)

  • Change in scores from pre-mid-post on the Falls Efficacy Scale-International and Activities Specific Balance Confidence Scale

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

  • Change in scores from pre-mid-post on the Short-Form Health Survey (SF-36)

    Comparing pre testing (week 0) to mid testing (week 6) and post-testing (week 12).

Other Outcomes (1)

  • Attendance rate to both live online and recorded dance classes throughout the 12-week intervention

    During the 12-week intervention period.

Study Arms (2)

Dancing control

ACTIVE COMPARATOR

The control group will complete online dance classes with the same dose, frequency and duration as the experimental group. They however will not wear blood flow restriction cuffs during the classes.

Other: Dance classes alone

Dancing blood flow restriction

EXPERIMENTAL

Participants in the blood flow restriction group will wear elasticized bands during the online dance classes. They will put them on before warm-up and take them off before cool-down.

Other: Blood flow restriction in combination with dance classesOther: Dance classes alone

Interventions

Blood flow restriction in combination with online ballet and modern-style dance classes to test if the balance of older women can be improved. Participants will wear 5 centimetre elasticized blood flow restriction bands on their proximal thighs throughout the online ballet-modern dance classes. Tightness levels will be set at a 7/10 of the perceived tightness scale used by Wilson et al. (2013), with a total restriction time of approximately 60 minutes, twice per week.

Dancing blood flow restriction

Online ballet and modern-dance inspired classes will be held on Zoom twice per week for 75 minutes. The sessions will span a 12 week time frame. All classes will begin with a warm-up, 1 plie exercise, 1 tendu exercise, a travelling ballet-inspired exercise, 1 travelling Graham or Limón modern dance exercise and a seated cool-down.

Dancing blood flow restrictionDancing control

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Female
  • Over 65 years old
  • Able to visit Concordia University for all testing sessions
  • Access to a device with a webcam, Zoom and stable internet
  • No contraindication for physical activity from their physician

You may not qualify if:

  • Occurrence/onset of a stroke, vertigo, concussion or lower-extremity injury during the 12-week intervention period
  • Presence of venous thromboembolism, peripheral vascular disease or sickle cell anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concordia University

Montreal, Quebec, H3G 1M8, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

January 9, 2023

Primary Completion

March 20, 2026

Study Completion

April 20, 2026

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations