NCT05310006

Brief Summary

The first study was a randomized crossover trial that compared the acute effects of High Speed Resistance Exercise (HSRE) and Traditional Resistance Exercise (TRE) on blood pressure parameters in a sample of frail older adults. Participants performed three experimental sessions (i.e., HSRE, TRE, and a control session \[CS\]) in a random order and separated from one another by seven days (standard deviation \[±\] 1 day). Food consumption was maintained constant during 48 h prior to the exercise session and a standard breakfast was offered 60-90 min before the beginning of the experimental sessions. The pharmacological therapy was kept constant during the whole study, and participants took their anti-hypertensive medication at the same time in all experimental days as prescribed by their physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

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

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

February 23, 2022

Last Update Submit

March 30, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Blood Pressure

    Blood Pressure

    Immediately after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    10 minutes after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    20 minutes after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    30 minutes after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    50 minutes after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    60 minutes after the end of the experimental sessions

  • Blood Pressure

    Blood Pressure

    24 hours after the end of the experimental sessions

Study Arms (3)

High Speed Resistance Exercise (HSRE)

EXPERIMENTAL

Exercise sessions performed using eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s.

Other: Exercise

Traditional Resistance Exercise (TRE)

EXPERIMENTAL

Exercise sessions were performed using four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s.

Other: Exercise

Control Session (CS)

NO INTERVENTION

Participants remained seated in a comfortable chair listening to music and/or talking with study investigators for approximately 30 min.

Interventions

Exercise sessions were performed in the morning (07:00 am-12:00 am) under the supervision of at least two fitness instructors in the rehabilitation unit of the nursing home.HSRE and TRE were designed according to the peculiarities of each type of resistance exercise (Chodzko-Zajko et al., 2009). During TRE, participants performed four sets of 8-10 repetitions at 70-75% of the maximal strength. The concentric and eccentric phases were carried out for 2 s. For HSRE, exercises were performed eight times (sets) with 4-5 repetitions at 70-75% of the maximal strength. The concentric phase was performed as fast as possible, and the eccentric phase was carried out for 2 s. Bilateral calf raise was performed using the same load as unilateral knee extension.

High Speed Resistance Exercise (HSRE)Traditional Resistance Exercise (TRE)

Eligibility Criteria

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

You may qualify if:

  • \- Aged ≥60 years; Frail according to Fried's criteria (Fried et al., 2009); Possessed sufficient physical and cognitive abilities to perform all exercises required by the protocol; Had a physician authorization to participate of exercise programs.

You may not qualify if:

  • Participation in a structured physical exercise training program in the past six months; Prescription of hormone replacement therapy and/or psychotropic drugs; Presence of any acute cardiovascular event (e.g., myocardial infarction) or complication in the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lar Mãe Mariana Nursing Home

Poá, São Paulo, 08562-460, Brazil

Location

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Hélio José Coelho Júnior

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 4, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations