NCT07662551

Brief Summary

study with multicomponent exercise

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

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

Study Start

First participant enrolled

August 25, 2025

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

24 days

First QC Date

May 29, 2026

Last Update Submit

June 17, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in lower limb muscle strength

    The assessments included tests of lower limb strength (sit-to-stand test) - In this test, the participant must sit down and stand up from a chair. The total number of repetitions in 30 seconds is recorded.

    Baseline and after 10 weeks

  • Change in upper limb strength

    Upper limb strength (forearm flexion test) - The forearm flexion test assesses upper body strength using two-kilogram dumbbells for women and four-kilogram dumbbells for men, a chair with a backrest (without armrests), and a stopwatch. The participant must be seated against the chair with an upright posture, performing the greatest number of bicep curls with their dominant hand in thirty seconds.

    Baseline and 10 weeks

  • Change in lower limb flexibility

    Lower limb flexibility (sit-and-reach test) - With the leg extended (but not overextended), the participant slowly leans forward, keeping the spine as straight as possible and the head aligned with the spine. The participant attempts to touch their toes by sliding their hands, one on top of the other, with the tips of their middle fingers, down the extended leg. The evaluator uses a 45 cm ruler and records the distance (cm) to the toes (minimum result) or the distance (cm) that can be reached beyond the toes (maximum result).

    Baseline and 10 weeks

  • Change in body balance

    agility/dynamic balance (sit-to-walk 2.44m and return to sit test) - The person being evaluated starts in a seated position in a chair with an upright posture, hands on thighs and feet on the floor with one foot slightly in front of the other. At the signal, the person being evaluated gets up from the chair (they can push off with their thighs or the chair), walks as quickly as possible around the cone, returns to the chair and sits down. For reliable timing, the evaluator should start the stopwatch at the signal movement, whether or not the person has started moving, and stop the stopwatch the exact moment the person sits down in the chair.

    Baseline and 10 weeks

  • Change in upper limb flexibility

    Upper limb flexibility (behind-the-back reach test) - Standing, the subject places their preferred hand on the same shoulder, palm open and fingers extended, reaching as far as possible to the middle of their back (elbow pointing upwards). The hand of the other arm is placed behind the back, palm upwards, reaching upwards as far as possible in an attempt to touch or overlap the extended middle fingers of both hands. Without moving the subject's hands, the evaluator helps to verify if the middle fingers of each hand are pointing towards each other. The overlap distance, or the distance between the tips of the middle fingers, is measured to the nearest centimeter. Negative results (-) represent the shortest distance between the middle fingers; positive results (+) represent the overlap of the middle fingers.

    Baseline and 10 weeks

  • Change in aerobic endurance

    Aerobic endurance (6-minute walk) - At the indicated signal, participants walk as fast as possible (without running) around the course as many times as they can within the time limit. During the test, participants may stop and rest if necessary, and then resume walking. The evaluator must move onto the course after all participants have started and must record the elapsed time. The 6-minute walk test uses a 45.7 m course measured in 4.57 m segments. The distance covered in the 6-minute interval will be assessed.

    Baseline and 10 weeks

Secondary Outcomes (7)

  • Change in body mass

    Baseline and 10 weeks

  • Height Assessment

    Baseline and 10 weeks

  • Change in waist circumference

    Baseline and 10 weeks

  • Change in hip circumference

    Baseline and 10 weeks

  • Change in Body Mass Index (BMI)

    Baseline and 10 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group (IG)

EXPERIMENTAL

The IG followed this protocol: Week 1 - Day 1: thirty minutes of aerobic resistance exercises and 30 minutes of balance exercises; Day 2: 30 minutes of balance exercises. Week 2 - Day 1: thirty minutes of strength exercises for upper and lower limbs and 30 minutes of balance exercises; Day 2: 30 minutes of balance exercises. After week 2, the training returned to week 1 until completing ten weeks. The balance exercises used in the classes were static and dynamic, with 6 to 7 exercises and a duration of 30 to 45 minutes. In the first three weeks, the balance exercises were performed with two sets of 12 to 15 repetitions. From the fourth week onwards, there was a progression to three sets of 12 repetitions, and in the last four weeks, the exercises were performed with four sets of 12 repetitions.

Behavioral: Balance exerciseBehavioral: Multicomponent exercises

Control

ACTIVE COMPARATOR

Week 1 - Days 1 and 2: 30 minutes of aerobic endurance exercises and 30 minutes of flexibility exercises. Week 2: Days 1 and 2: 30 minutes of strength training for upper and lower limbs and 30 minutes of balance exercises. After week 2, the training returned to week 1 until completing the ten weeks.

Behavioral: Multicomponent exercises

Interventions

Participants who were randomized to the intervention group performed 10 weeks of body balance exercise.

Intervention Group (IG)

Participants who were randomized to the intervention or control group performed 10 weeks of multicomponent exercise.

ControlIntervention Group (IG)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • Older adults
  • Over 50 years of age of both sexes
  • Participating in an extension program at Federal University of Pará
  • Self-reported diagnosis of hypertension.

You may not qualify if:

  • Participants who did not agree with the study
  • Participants Who have low attendance in classes (below 50%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Pará

Castanhal, Pará, 68746-630, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 23, 2026

Study Start

August 25, 2025

Primary Completion

September 18, 2025

Study Completion

December 2, 2025

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations