NCT04868071

Brief Summary

The present study refers to a three-arm randomized controlled trial that investigated the effects of two types of RT on frailty status, physical performance, cognitive function, and blood pressure of prefrail and frail older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

October 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 22, 2021

Last Update Submit

April 27, 2021

Conditions

Frailty

Outcome Measures

Primary Outcomes (4)

  • Frailty Status

    Frailty status will be assessed using the Fried Frailty Phenotype Scale published in 2001.

    16 weeks

  • Physical Performance

    Physical Performance will be assessed using the sit-to-stand test.

    16 weeks

  • Cognitive Function

    Cognition will be assessed using the Mini Mental State Examination

    16 weeks

  • Blood Pressure

    16 weeks

Study Arms (3)

High-Speed Resistance Training

EXPERIMENTAL

Participants performed exercises 8 times (sets) with 3-5 repetitions at 70%-75% of the maximal strength.

Behavioral: Physical Exercise

Low-Speed Resistance Training

EXPERIMENTAL

Participants performed exercises 4 times (sets) with 8-10 repetitions at 70%-75% of the maximal strength.

Behavioral: Physical Exercise

Control Group

NO INTERVENTION

No activities

Interventions

Physical ExerciseBEHAVIORAL

Exercise interventions were carried out over a total of 16 weeks in the mornings (08:00 am-12:00 am) under the supervision of at least two fitness instructors. Participants performed four exercises for lower limbs (Figure 9): 1st) squat on the chair, 2nd) seated unilateral hip flexion, 3rd) seated unilateral knee extension, and 4th) bilateral calf raise with 12-15 submaximal repetitions avoiding fatigue (i.e., inability to complete a repetition in a full range of motion). The number of sets was increased linearly during the first month, such that one set was performed in the 1st week, two sets in the 2nd week, 3 sets in the 3rd week, and 4 sets in the 4th week. Subsequently, participants performed the main exercise period. After a brief warm-up, participants performed the same exercises that were performed during the familiarization period using an adjustable weight vest and ankle weights (DOMYOS®, Shangai, China).

Also known as: Resistance Training
High-Speed Resistance TrainingLow-Speed Resistance Training

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a) aged 60 years or over; b) were prefrail or frail according to Fried's criteria; c) performed the sit-to-stand test alone, with a mobility aid, or researcher's help; d) possessed sufficient physical and cognitive abilities to perform exercise sessions; and e) had a physician authorization to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cantinho do Idoso Senior Center

Poá, São Paulo, Brazil

Location

Mãe Maria Nursing Home

Poá, São Paulo, Brazil

Location

Related Publications (1)

  • Coelho-Junior HJ, Uchida MC. Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status, Physical Performance, Cognitive Function, and Blood Pressure in Prefrail and Frail Older Adults. Front Med (Lausanne). 2021 Jul 26;8:702436. doi: 10.3389/fmed.2021.702436. eCollection 2021.

    PMID: 34381802DERIVED

MeSH Terms

Conditions

Frailty

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 30, 2021

Study Start

October 1, 2017

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(2)