NCT02702557

Brief Summary

This feasibility study investigates if frail elderly and hospitalized patients are able to perform unsupervised elastic band exercises as a supplement to their usual supervised physiotherapy sessions and how much training they perform during their hospitalization. It is also investigated how the frail elderly and the health personnel experiences the unsupervised elastic band exercises.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

February 29, 2016

Last Update Submit

May 2, 2016

Conditions

Keywords

Frail ElderlyElastic Band ExercisesUnsupervised ExercisesMonitoring TechnologyBandcizerAdherenceFeasibility

Outcome Measures

Primary Outcomes (1)

  • Total number of sets performed

    From inclusion-discharge from hospital - up to 6 weeks

Secondary Outcomes (1)

  • The total number of repetitions performed

    From inclusion-discharge from hospital - up to 6 weeks

Other Outcomes (2)

  • Mean deviation from the prescribed TUT per repetition in seconds during the course of the intervention

    From inclusion-discharge from hospital - up to 6 weeks

  • Difference in score of two tests: The 30-s chair stand and the de Morton Mobility Index (DEMMI)

    From beginning of hospitalization to discharge from hospital - up to 6 weeks

Study Arms (1)

Elastic Band Exercises

OTHER

Unsupervised Elastic band exercises performed once a day until the patient is discharged from the hospital. One exercise for the upper extremity (row exercise level 1-3) and one exercise for the lower extremity (knee extension level 1-3). The two exercises are both performed as 3 sets of 10 repetitions.

Other: Elastic Band Exercises

Interventions

Also known as: Bandcizer
Elastic Band Exercises

Eligibility Criteria

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

You may qualify if:

  • Frail elderly and hospitalized patients with a minimal score of 5/15 measured by the Tilburg Frailty Indicator
  • Able to read and understand Danish

You may not qualify if:

  • Frail elderly and hospitalized patients with a score of \<5 measured by the Short Portable Mental Status Questionnaire
  • Frail elderly and hospitalized patients where resistance training and physical activity is contraindicated (evaluated by a geriatrician and/or physiotherapist)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, North Region Denmark, 9000, Denmark

Location

Related Publications (1)

  • Rathleff CR, Bandholm T, Spaich EG, Jorgensen M, Andreasen J. Unsupervised progressive elastic band exercises for frail geriatric inpatients objectively monitored by new exercise-integrated technology-a feasibility trial with an embedded qualitative study. Pilot Feasibility Stud. 2017 Nov 13;3:56. doi: 10.1186/s40814-017-0202-3. eCollection 2017.

Study Officials

  • Jane Andreasen, ph.d. stud.

    Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 8, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations