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RTF: Effects of Low-Speed and High-Speed Resistance Training Programs on Frailty Status

Sponsor
University of Campinas, Brazil (Other)
Overall Status
Completed
CT.gov ID
NCT04868071
Collaborator
(none)
122
Enrollment
2
Locations
3
Arms
22.9
Actual Duration (Months)
61
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical Exercise
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
122 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Aug 29, 2019
Actual Study Completion Date :
Aug 29, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: High-Speed Resistance Training

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

Behavioral: Physical Exercise
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).
Other Names:
  • Resistance Training

    		•
    Experimental: Low-Speed Resistance Training

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

    Behavioral: Physical Exercise
    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).
    Other Names:
  • Resistance Training

    		•
    No Intervention: Control Group

    No activities

    Outcome Measures

    Primary Outcome Measures

    1. Frailty Status [16 weeks]

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

    2. Physical Performance [16 weeks]

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

    3. Cognitive Function [16 weeks]

      Cognition will be assessed using the Mini Mental State Examination

    4. Blood Pressure [16 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cantinho do Idoso Senior Center Poá SP Brazil
    2 Mãe Maria Nursing Home Poá SP Brazil

    Sponsors and Collaborators

    • University of Campinas, Brazil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hélio José Coelho Júnior, Principal Investigator, University of Campinas, Brazil
    ClinicalTrials.gov Identifier:
    NCT04868071
    Other Study ID Numbers:
    • 20021919.7.0000.5404
    First Posted:
    Apr 30, 2021
    Last Update Posted:
    Apr 30, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Frailty

    Study Results

    No Results Posted as of Apr 30, 2021