NCT06040554

Brief Summary

The purpose of the present study is to investigate the effectiveness of a resistance exercise program consisting of elastic band exercises to balance, strength and quality of life of community-dwelling elders. The hypothesis of the study is that the people training with elastic bands will show benefits on the aforementioned areas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

September 6, 2023

Last Update Submit

September 13, 2023

Conditions

Aging WellAging

Keywords

agingelderlystrengthbalanceelastic band

Outcome Measures

Primary Outcomes (1)

  • Berg Balance Scale

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

    At baseline and after the end of the 8th week of the training program, at week number 9

Secondary Outcomes (6)

  • Gait Speed 4 Meters

    At baseline and after the end of the 8th week of the training program, at week number 9

  • Timed Up and Go

    At baseline and after the end of the 8th week of the training program, at week number 9

  • 30 Seconds Chair Stand Test

    At baseline and after the end of the 8th week of the training program, at week number 9

  • Handgrip Strength

    Prior to the 1st week of the training program, After the end of the 8th week of the training program

  • Lower Limb Strength (Flexors - Extensors of Knee)

    At baseline and after the end of the 8th week of the training program, at week number 9

  • +1 more secondary outcomes

Study Arms (2)

Exercise Program

EXPERIMENTAL

Participants will participate in a group resistance exercise program for 8 weeks, using elastic bands.

Other: Elastic Band Resistance Exercises

Unchanged Activities of Daily Living

NO INTERVENTION

Participants will be asked not to change their activities of daily living for the duration of the research.

Interventions

Elastic Band Resistance ExercisesOTHER

8 Warm-Up Exercises followed by 10 Elastic Band Exercises followed by 8 Post-Workout Exercises.

Exercise Program

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Over 65 years old
  • Able to consent to participation
  • Able to stand without assistive devices
  • Able to participate in strength training
  • Able to perform activities of Daily Living independently
  • Cognitively and psychologically able to participate in a group setting

You may not qualify if:

  • Systematically exercised for up to 6 months prior to start of study
  • Neurological disorders or inability to stand
  • Recent surgery or contraindications to exercise
  • Arthroplasty or Prosthetic Limbs
  • Vision or Hearing problems hindering participation in group
  • Medication or Disorders contraindicating exercise or standing
  • Hypotension or Orthostatic Hypotension
  • Malignancy or Recent Treatment for Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elderly Community Center

Athens, Attica, Greece

Location

Study Officials

  • K Kontonikas

    University West Attica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

K Kontonikas

CONTACT

694062554mscphys21004@uniwa.gr

N Chrisagis, Phd

CONTACT

nchrisagis@uniwa.gr

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
Principal Investigator

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 15, 2023

Study Start

September 20, 2023

Primary Completion

November 30, 2023

Study Completion

December 1, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)