NCT03951688

Brief Summary

Aim: To evaluate the short-term effects of a multi-modal exercise program on physical performance variables in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

May 14, 2019

Last Update Submit

February 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timed 'Up-and-Go' test (TUG)

    The participants are instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials are performed, and the quicker time in seconds is recorded. Shorter time indicates better performance.

    16 weeks

Secondary Outcomes (2)

  • Repeated chair stand test (STS-5)

    16 weeks

  • One-Leg Stand test (OLS)

    16 weeks

Study Arms (2)

Experimental-Multi-modal exercise program

EXPERIMENTAL

Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.

Other: Experimental-Multi-modal exercise program

Control Group

NO INTERVENTION

No intervention

Interventions

Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.

Experimental-Multi-modal exercise program

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 65 years
  • Community-dwelling

You may not qualify if:

  • Unable to ambulate independently
  • Mini-mental state examination score \< 24
  • Barthel Index score \< 80
  • Unstable cardiovascular disease
  • Neurological disorder that could compromise exercising
  • Upper or lower-extremity fracture in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Study Officials

  • JF Lisón, PhD

    Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 15, 2019

Study Start

May 31, 2019

Primary Completion

December 28, 2019

Study Completion

January 10, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations