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Effects of an exercise protocol in standing over sedentary lifestyle of frail elderly

Effects of an exercise protocol in orthostatism over sedentary behavior of frail elderly: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8w35rx
Enrollment
Unknown
Registered
2018-10-02
Start date
2017-08-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedentary behavior

Interventions

Experimental Group: 18 elderly will be oriented and accompanied weekly through telephone call to carry out a protocol of home exercises for a period of 4 months. Participants will receive a brochure c
Other
G11.427.410.698.277
F01.100.150.750.500.600
G11.427.690

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Elderly over 60 years; diagnosis of Fragility evidenced by the presence of at least 3 of the 5 criteria: weight loss will be considered for unintentional loss greater than 4Kg in the last year or 5% of body weight, fatigue, physical inactivity, muscle weakness and slow gait; difficulty in mobility; non-participation in other exercise programs; acceptance in signing the trial Consent Form.

Exclusion criteria

Exclusion criteria: Inability to stay standing; impossibility to perform the exercise due to any type of clinical change or adverse effects such as pain, cardiorespiratory, orthopedic, mental or neurological changes; elderly with increased risk for falls without family or professional follow-up of a caregiver for the practice of home exercises.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: reduction of the sedentary behavior of the elderly, measured by accelerometer brand ActiGraph, model GT3x, fixed with a elastic belt around the right hip, for a period of 7 consecutive days, withdrawn only for the bath. Data collected before the intervention, at the end of the intervention (lasting 4 months) and 1 month after the intervention. Only the days on which the device is used for a period of 10 hours per day will be considered valid, and at least 5 valid days will be necessary. Sedentary time per day, number and duration of sedentary time breaks per day and the sedentary accumulation of time for periods of 10 consecutive minutes or more. The cut-off point used to define the sedentary behavior will be less than 100 counts per minute as measured by the accelerometer. For the analysis of the data obtained by this device will be used the software Actilife, provided by the manufacturer. It was considered an effect size of 0.25, 5% alpha and power of 80%

Secondary

MeasureTime frame
Expected outcome 2: improvement postural control assessed through the SPPB scale (Short Physical Performance Battery), with a statistically significant pre and post-test difference (significance level considered 5%). Data collected at the beginning, after 2 months, after 4 months and 1 month after the intervention;Expected outcome 3: improvement mobility assessed through the Life Space Assessment (LSA) scale, with a statistically significant pre and post-test difference (significance level considered 5%). Data collected at the beginning, after 2 months, after 4 months and 1 month after the intervention ;Expected outcome 4: increasing the number of steps per day assessed through the accelerometer, with a statistically significant pre and post-test difference (significance level considered 5%). Data collected at the beginning, after 2 months, after 4 months and 1 month after the intervention;Expected outcome 5: adherence to the treatment, verified through the self-report of the elderly about the total time spent to perform the exercises, collected during the 4 months of intervention;Expected outcome 6: safety, evaluated by recording the possible adverse effects such as: discomfort, over tiredness, dizziness, shortness of breath, palpitation, falling, fainting or chest pain or any other adverse effect related to the intervention. Data collected during the 4 months of intervention

Countries

Brazil

Contacts

Public ContactFabiana ;Jose Tosi;Pompeu

Hospital das Clinicas da Faculdade de Medicina da USP;Hospital das Clinicas da Faculdade de Medicina da USP

tosi.fisio@gmail.com;jose.pompeu@fm.usp.br+5511 995013607;+5511 3091-8424

Outcome results

None listed

Source: REBEC (via WHO ICTRP)