Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status (RTF)
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.
Sites / Locations
- Cantinho do Idoso Senior Center
- Mãe Maria Nursing Home
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
High-Speed Resistance Training
Low-Speed Resistance Training
Control Group
Arm Description
Participants performed exercises 8 times (sets) with 3-5 repetitions at 70%-75% of the maximal strength.
Participants performed exercises 4 times (sets) with 8-10 repetitions at 70%-75% of the maximal strength.
No activities
Outcomes
Primary Outcome Measures
Frailty Status
Frailty status will be assessed using the Fried Frailty Phenotype Scale published in 2001.
Physical Performance
Physical Performance will be assessed using the sit-to-stand test.
Cognitive Function
Cognition will be assessed using the Mini Mental State Examination
Blood Pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT04868071
First Posted
April 22, 2021
Last Updated
April 27, 2021
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT04868071
Brief Title
Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status
Acronym
RTF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 29, 2019 (Actual)
Study Completion Date
August 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-Speed Resistance Training
Arm Type
Experimental
Arm Description
Participants performed exercises 8 times (sets) with 3-5 repetitions at 70%-75% of the maximal strength.
Arm Title
Low-Speed Resistance Training
Arm Type
Experimental
Arm Description
Participants performed exercises 4 times (sets) with 8-10 repetitions at 70%-75% of the maximal strength.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No activities
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Other Intervention Name(s)
Resistance Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Frailty Status
Description
Frailty status will be assessed using the Fried Frailty Phenotype Scale published in 2001.
Time Frame
16 weeks
Title
Physical Performance
Description
Physical Performance will be assessed using the sit-to-stand test.
Time Frame
16 weeks
Title
Cognitive Function
Description
Cognition will be assessed using the Mini Mental State Examination
Time Frame
16 weeks
Title
Blood Pressure
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Exclusion criteria included having participated in a structured physical exercise training program in the past six months, prescription of hormone replacement therapy and/or psychotropic drugs, and any unstable cardiovascular event (e.g., myocardial infarction) or complication in the past 6 months.
Facility Information:
Facility Name
Cantinho do Idoso Senior Center
City
Poá
State/Province
SP
Country
Brazil
Facility Name
Mãe Maria Nursing Home
City
Poá
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34381802
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status
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