Effects of an Exercise Program Based on Muscle Strengthening in the Rehabilitation of Individuals Undergoing Total Hip Arthroplasty: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- 6 Weeks Post-Intervention Muscle Strength
研究概览
简要总结
Subjects submitted to unilateral THA will be randomized into two rehabilitation groups. One group will receive a booklet with guidelines for postoperative care, while the other group will participate in face-to-face sessions with exercises with emphasis on muscle strengthening.
详细描述
Individuals with osteoarthritis (OA) of the hip submitted to total hip arthroplasty (THA) may present alterations in their functional capacity, and associated, among other aspects, the reduction in muscle strength. Our overall objective is to compare the effects of an exercise program based on training of muscular strength to orientations and functional home exercises in patients submitted to THA, as well as to compare the outcomes of both groups with those of healthy individuals. Individuals with THA will be randomly assigned to two groups. One group will receive face-to-face treatment (G1) and the other will receive postoperative guidance (G2). A blinded appraiser regarding the allocation will apply the evaluation tools at the moments: preintervention, after completing 7 days and after 10 weeks of the end of the treatment. The research will present as clinical outcomes: the muscular strength, through the values of torque peaks obtained in dynamometry; the functional capacity through the results of the Timed Up and Go test and the Harris Hip Score questionnaire; the range of joint motion measured with and flexometer; the pain through the results of the numerical scale of pain; and kinesiophobia, through the scores obtained in the Tampa Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The random allocation step will be conducted through Randomizers - www.random.org by a research assistant. The assistant responsible for randomization will not be involved in any other phase of the study and the secrecy of the allocation will be maintained through opaque envelopes. A second independent assistant will administer the agenda and all communication between the participants and the researchers involved
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred by orthopedic doctors of the city of Porto Alegre, Rio Grande do Sul, Brazil;
- •Between 30-60 days of unilateral total hip arthroplasty (cemented and hybrid prostheses) postoperative phase;
- •Read and consent to the Free and Informed Consent Form and understood the guidelines necessary to carry out the evaluations proposed in this research.
排除标准
- •Performing a surgical procedure, in the last six months, in other articular joints in the lower limbs;
- •previous surgical procedures in the coxofemoral joint;
- •surgical procedures and osteoarticular diseases in the lumbar spine;
- •osteoarticular diseases in lower limb joints;
- •muscle injuries in lower limbs;
- •presence of signs or symptoms of osteoarthritis in the contralateral hip;
- •postoperative complications such as prosthesis dislocation, deep venous thrombosis, periarticular fractures and neural lesions;
- •intra-articular injection of corticosteroids in the lower limbs during the last six months;
- •cardiovascular diseases with presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
- •presence of neurological diseases.
结局指标
主要结局
6 Weeks Post-Intervention Muscle Strength
时间窗: Will be measured post intervention 6 weeks after intervention).
Muscle strength will be measured by a portable dynamometer and represented as muscle torque (N.m).
次要结局
- Functional Capacity (TUG)(Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).)
- Functional Capacity (HHS)(Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).)
- Hip Range of Motion(Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).)
- Pain in the operated hip (last seven days)(Will be measured pre-intervention (30 days after the surgery), and two moments post intervention (1 week after intervention and 6 weeks after intervention).)
- 1 Week Post-Intervention Muscle Strength(Will be measured post intervention (1 week after intervention).)
- Pre-Intervention Muscle Strength(Will be measured pre-intervention (30 days after the surgery).)
研究者
Bruna de Moraes Lopes
Principal Investigator (PhD student)
Federal University of Health Science of Porto Alegre