NCT02981771

Brief Summary

Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2017

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

November 29, 2016

Last Update Submit

October 13, 2018

Conditions

AgingCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in Balance ability - a composite outcome

    In order to assess changes in balance ability, it will be measured with the following tests: Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared

    4 months

Study Arms (2)

experiment

EXPERIMENTAL

A physical activity program that is based on balance and coordination exercises

Behavioral: Balance activity program

control

PLACEBO COMPARATOR

A physical activity program that is based on strength exercises

Behavioral: Strength activity program

Interventions

Balance activity programBEHAVIORAL

Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises

experiment
Strength activity programBEHAVIORAL

Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises

control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Has Cardiovascular disease, under the supervision of a cardiologist
  • Participates in a cardiovascular rehabilitation center
  • Able to undergo physical activity for 60 minutes twice a week

You may not qualify if:

  • All Other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zinman College for Physical Education and Sport Sciences

Ramot Naftali, 42902, Israel

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

February 8, 2017

Primary Completion

July 31, 2017

Study Completion

December 25, 2017

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

IL(1)